Trial Outcomes & Findings for Developing New Treatments for Tourette Syndrome: Therapeutic Trials With Modulators of Glutamatergic Neurotransmission (NCT NCT01018056)
NCT ID: NCT01018056
Last Updated: 2018-01-30
Results Overview
The primary outcome measure is effective tic suppression as determined by the difference in the Total Tic subscale (TTS) scores of the Yale Global Tic Severity Scale (YGTSS) at baseline and 6 weeks. i) Yale Global Tic Severity Scale (YGTSS): The YGTSS is a semi-structured clinical interview designed to measure current tic severity. It is comprised of two parts, a tic score (0-50) and a total impairment score (0-50). The Total Tic Score (TTS: 0-50) has been selected as the primary outcome measure. The scale ranges from 0 (the best possible outcome) to 50 (the worst possible outcome). This scale is considered the best currently available scale to rate the severity of tics. The data provided below represents the mean change (baseline minus six week) for the D-serine group (n = 9), Riluzole (n = 10), and Placebo group (n = 5). For consistency, all values weather positive or negative represent baseline minus week 6.
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
39 participants
Primary outcome timeframe
Baseline and 6-weeks
Results posted on
2018-01-30
Participant Flow
Consent will be obtained by Dr. Harvey Singer from eligible patients at the Tourette Syndrome Clinic in the JHH Outpatient Center. Patients will be given a general synopsis of the research study and carefully explained each page of the consent form. Once informed consent is obtained, the subject will be considered to have entered the study.
39 patients were enrolled at a screening visit, but for a variety of reasons (i.e. no longer interested, concerned about blood draws, medication use, et cetera) only 30 started medications at the baseline visit. Of these 30, 24 completed the study.
Participant milestones
| Measure |
D-serine (Glutamate Agonist)
24 subjects age 8-17 years with moderate to severe TS (TTS \> 22) will be enrolled in this treatment arm. They will receive D-serine for 6-weeks of the study, during which time drug dose may gradually be increased as needed. At 6-weeks participants will taper off drug.
D-serine: The dosage schedule will be flexible with a maximum dose for each subject being 30 mg/kg/day. In any individual subject, dose escalation may proceed more slowly, or the dose may be reduced if necessary. At the 4 week visit, if an additional dosage increase is prescribed by Dr Singer, the pharmacy will provide an additional vial of capsules labeled as study drug, but containing either 250 or 500 mg tablets of D-serine or placebo; capsule content to be determined by patient's weight. No changes in dosage will be made during the final week of treatment.
|
Riluzole (Glutamate Antagonist)
24 subjects age 8-17 years with moderate to severe TS (TTS \> 22) will be enrolled in this treatment arm. They will receive riluzole for 6-weeks of the study, during which time drug dose may gradually be increased as needed. At 6-weeks participants will taper off drug.
Riluzole: The starting dose of riluzole will be 50 mg for one week; administered as one capsule (50) every morning. Dosage schedules will be flexible. If needed for tic suppression, the dose will be increased weekly by 50 mg and given in BID doses. The maximum dose will be 200 mg/day (administered as 2 capsules BID). In any individual subject, dose escalation may proceed more slowly, or the dose may be reduced if necessary. At the 4 week visit, if an additional dosage increase is prescribed by Dr Singer, the pharmacy will provide an additional vial of 14 capsules labeled as study drug, but containing placebo capsules. No changes in dosage will be made during the final week of treatment.
|
Placebo
12 subjects age 8-17 years with moderate to severe TS (TTS \> 22) will be enrolled in this treatment arm. They will receive placebo for 6-weeks of the study, during which time drug dose may gradually be increased as needed. At 6-weeks participants will taper off drug.
Placebo: Placebo tablets will be formulated in look-alike capsules. At the 4 week visit, if an additional dosage increase is prescribed by Dr Singer, the pharmacy will provide an additional vial of 14 capsules labeled as study drug, but containing additional placebo capsules.
|
|---|---|---|---|
|
Overall Study
STARTED
|
12
|
12
|
6
|
|
Overall Study
COMPLETED
|
9
|
10
|
5
|
|
Overall Study
NOT COMPLETED
|
3
|
2
|
1
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Developing New Treatments for Tourette Syndrome: Therapeutic Trials With Modulators of Glutamatergic Neurotransmission
Baseline characteristics by cohort
| Measure |
D-serine (Glutamate Agonist)
n=9 Participants
24 subjects age 8-17 years with moderate to severe TS (TTS \> 22) will be enrolled in this treatment arm. They will receive D-serine for 6-weeks of the study, during which time drug dose may gradually be increased as needed. At 6-weeks participants will taper off drug.
D-serine: The dosage schedule will be flexible with a maximum dose for each subject being 30 mg/kg/day. In any individual subject, dose escalation may proceed more slowly, or the dose may be reduced if necessary. At the 4 week visit, if an additional dosage increase is prescribed by Dr Singer, the pharmacy will provide an additional vial of capsules labeled as study drug, but containing either 250 or 500 mg tablets of D-serine or placebo; capsule content to be determined by patient's weight. No changes in dosage will be made during the final week of treatment.
|
Riluzole (Glutamate Antagonist)
n=10 Participants
24 subjects age 8-17 years with moderate to severe TS (TTS \> 22) will be enrolled in this treatment arm. They will receive riluzole for 6-weeks of the study, during which time drug dose may gradually be increased as needed. At 6-weeks participants will taper off drug.
Riluzole: The starting dose of riluzole will be 50 mg for one week; administered as one capsule (50) every morning. Dosage schedules will be flexible. If needed for tic suppression, the dose will be increased weekly by 50 mg and given in BID doses. The maximum dose will be 200 mg/day (administered as 2 capsules BID). In any individual subject, dose escalation may proceed more slowly, or the dose may be reduced if necessary. At the 4 week visit, if an additional dosage increase is prescribed by Dr Singer, the pharmacy will provide an additional vial of 14 capsules labeled as study drug, but containing placebo capsules. No changes in dosage will be made during the final week of treatment.
|
Placebo
n=5 Participants
12 subjects age 8-17 years with moderate to severe TS (TTS \> 22) will be enrolled in this treatment arm. They will receive placebo for 6-weeks of the study, during which time drug dose may gradually be increased as needed. At 6-weeks participants will taper off drug.
Placebo: Placebo tablets will be formulated in look-alike capsules. At the 4 week visit, if an additional dosage increase is prescribed by Dr Singer, the pharmacy will provide an additional vial of 14 capsules labeled as study drug, but containing additional placebo capsules.
|
Total
n=24 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
14.4 years
STANDARD_DEVIATION 3.04 • n=5 Participants
|
13.1 years
STANDARD_DEVIATION 1.98 • n=7 Participants
|
12.6 years
STANDARD_DEVIATION 2.76 • n=5 Participants
|
13.5 years
STANDARD_DEVIATION 2.58 • n=4 Participants
|
|
Age, Categorical
<=18 years
|
9 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
24 Participants
n=4 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
6 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
21 Participants
n=4 Participants
|
|
Region of Enrollment
United States
|
9 participants
n=5 Participants
|
10 participants
n=7 Participants
|
5 participants
n=5 Participants
|
24 participants
n=4 Participants
|
PRIMARY outcome
Timeframe: Baseline and 6-weeksThe primary outcome measure is effective tic suppression as determined by the difference in the Total Tic subscale (TTS) scores of the Yale Global Tic Severity Scale (YGTSS) at baseline and 6 weeks. i) Yale Global Tic Severity Scale (YGTSS): The YGTSS is a semi-structured clinical interview designed to measure current tic severity. It is comprised of two parts, a tic score (0-50) and a total impairment score (0-50). The Total Tic Score (TTS: 0-50) has been selected as the primary outcome measure. The scale ranges from 0 (the best possible outcome) to 50 (the worst possible outcome). This scale is considered the best currently available scale to rate the severity of tics. The data provided below represents the mean change (baseline minus six week) for the D-serine group (n = 9), Riluzole (n = 10), and Placebo group (n = 5). For consistency, all values weather positive or negative represent baseline minus week 6.
Outcome measures
| Measure |
D-serine (Glutamate Agonist)
n=9 Participants
24 subjects age 8-17 years with moderate to severe TS (TTS \> 22) will be enrolled in this treatment arm. They will receive D-serine for 6-weeks of the study, during which time drug dose may gradually be increased as needed. At 6-weeks participants will taper off drug.
D-serine: The dosage schedule will be flexible with a maximum dose for each subject being 30 mg/kg/day. In any individual subject, dose escalation may proceed more slowly, or the dose may be reduced if necessary. At the 4 week visit, if an additional dosage increase is prescribed by Dr Singer, the pharmacy will provide an additional vial of capsules labeled as study drug, but containing either 250 or 500 mg tablets of D-serine or placebo; capsule content to be determined by patient's weight. No changes in dosage will be made during the final week of treatment.
|
Riluzole (Glutamate Antagonist)
n=10 Participants
24 subjects age 8-17 years with moderate to severe TS (TTS \> 22) will be enrolled in this treatment arm. They will receive riluzole for 6-weeks of the study, during which time drug dose may gradually be increased as needed. At 6-weeks participants will taper off drug.
Riluzole: The starting dose of riluzole will be 50 mg for one week; administered as one capsule (50) every morning. Dosage schedules will be flexible. If needed for tic suppression, the dose will be increased weekly by 50 mg and given in BID doses. The maximum dose will be 200 mg/day (administered as 2 capsules BID). In any individual subject, dose escalation may proceed more slowly, or the dose may be reduced if necessary. At the 4 week visit, if an additional dosage increase is prescribed by Dr Singer, the pharmacy will provide an additional vial of 14 capsules labeled as study drug, but containing placebo capsules. No changes in dosage will be made during the final week of treatment.
|
Placebo
n=5 Participants
12 subjects age 8-17 years with moderate to severe TS (TTS \> 22) will be enrolled in this treatment arm. They will receive placebo for 6-weeks of the study, during which time drug dose may gradually be increased as needed. At 6-weeks participants will taper off drug.
Placebo: Placebo tablets will be formulated in look-alike capsules. At the 4 week visit, if an additional dosage increase is prescribed by Dr Singer, the pharmacy will provide an additional vial of 14 capsules labeled as study drug, but containing additional placebo capsules.
|
|---|---|---|---|
|
The Change From Baseline to 6-week Scores for The Total Tic Subscale (TTS)
|
6.2 units on a scale
Standard Deviation 8.1
|
10.5 units on a scale
Standard Deviation 7.2
|
10.2 units on a scale
Standard Deviation 4.3
|
SECONDARY outcome
Timeframe: Baseline and 6-weeksi) Yale Global Tic Severity Scale (YGTSS): The YGTSS is a semi-structured clinical interview designed to measure current tic severity. It is comprised of two parts, a tic score (0-50) and a total impairment score (0-50), total maximum score is 100. This scale has established validity, as assessed by Dr. Walkup and colleagues and is considered the best currently available scale to rate the severity of tics. This scale ranges from 0 (the best possible outcome) to 100 (the worst possible outcome). The data provided below represents the mean change (baseline minus six week) for the D-serine group (n = 9), Riluzole (n = 10), and Placebo group (n = 5). For consistency, all values weather positive or negative represent baseline minus week 6. Please note that summary data (mean and standard deviation per group) were intended to be reported, and not participant level data (i.e. each individual data point of every subject per group).
Outcome measures
| Measure |
D-serine (Glutamate Agonist)
n=9 Participants
24 subjects age 8-17 years with moderate to severe TS (TTS \> 22) will be enrolled in this treatment arm. They will receive D-serine for 6-weeks of the study, during which time drug dose may gradually be increased as needed. At 6-weeks participants will taper off drug.
D-serine: The dosage schedule will be flexible with a maximum dose for each subject being 30 mg/kg/day. In any individual subject, dose escalation may proceed more slowly, or the dose may be reduced if necessary. At the 4 week visit, if an additional dosage increase is prescribed by Dr Singer, the pharmacy will provide an additional vial of capsules labeled as study drug, but containing either 250 or 500 mg tablets of D-serine or placebo; capsule content to be determined by patient's weight. No changes in dosage will be made during the final week of treatment.
|
Riluzole (Glutamate Antagonist)
n=10 Participants
24 subjects age 8-17 years with moderate to severe TS (TTS \> 22) will be enrolled in this treatment arm. They will receive riluzole for 6-weeks of the study, during which time drug dose may gradually be increased as needed. At 6-weeks participants will taper off drug.
Riluzole: The starting dose of riluzole will be 50 mg for one week; administered as one capsule (50) every morning. Dosage schedules will be flexible. If needed for tic suppression, the dose will be increased weekly by 50 mg and given in BID doses. The maximum dose will be 200 mg/day (administered as 2 capsules BID). In any individual subject, dose escalation may proceed more slowly, or the dose may be reduced if necessary. At the 4 week visit, if an additional dosage increase is prescribed by Dr Singer, the pharmacy will provide an additional vial of 14 capsules labeled as study drug, but containing placebo capsules. No changes in dosage will be made during the final week of treatment.
|
Placebo
n=5 Participants
12 subjects age 8-17 years with moderate to severe TS (TTS \> 22) will be enrolled in this treatment arm. They will receive placebo for 6-weeks of the study, during which time drug dose may gradually be increased as needed. At 6-weeks participants will taper off drug.
Placebo: Placebo tablets will be formulated in look-alike capsules. At the 4 week visit, if an additional dosage increase is prescribed by Dr Singer, the pharmacy will provide an additional vial of 14 capsules labeled as study drug, but containing additional placebo capsules.
|
|---|---|---|---|
|
The Change From Baseline to 6-week Scores for the Yale Global Tic Severity Scale (YGTSS) Total Score.
|
22 units on a scale
Standard Deviation 16.3
|
23.5 units on a scale
Standard Deviation 11.5
|
19.4 units on a scale
Standard Deviation 10.6
|
SECONDARY outcome
Timeframe: Baseline and 6-weeksClinical Global Impression-Improvement (CGI-I): The CGI-I is used to compare current severity to baseline. A score of 1 corresponds to "very much improved"; 2 equals "much improved;" 3 denotes "minimal change"; and 4 represents "no change." Scores above 4 are used to indicate deterioration, i.e., 5 equals "minimally worse;" 6 is "much worse;" and 7 is "very much worse." The data provided below represents the mean change (baseline minus six week) for the D-serine group (n = 9), Riluzole (n = 10), and Placebo group (n = 5). For consistency, all values weather positive or negative represent baseline minus week 6. Please note that summary data (mean and standard deviation per group) were intended to be reported, and not participant level data (i.e. each individual data point of every subject per group).
Outcome measures
| Measure |
D-serine (Glutamate Agonist)
n=9 Participants
24 subjects age 8-17 years with moderate to severe TS (TTS \> 22) will be enrolled in this treatment arm. They will receive D-serine for 6-weeks of the study, during which time drug dose may gradually be increased as needed. At 6-weeks participants will taper off drug.
D-serine: The dosage schedule will be flexible with a maximum dose for each subject being 30 mg/kg/day. In any individual subject, dose escalation may proceed more slowly, or the dose may be reduced if necessary. At the 4 week visit, if an additional dosage increase is prescribed by Dr Singer, the pharmacy will provide an additional vial of capsules labeled as study drug, but containing either 250 or 500 mg tablets of D-serine or placebo; capsule content to be determined by patient's weight. No changes in dosage will be made during the final week of treatment.
|
Riluzole (Glutamate Antagonist)
n=10 Participants
24 subjects age 8-17 years with moderate to severe TS (TTS \> 22) will be enrolled in this treatment arm. They will receive riluzole for 6-weeks of the study, during which time drug dose may gradually be increased as needed. At 6-weeks participants will taper off drug.
Riluzole: The starting dose of riluzole will be 50 mg for one week; administered as one capsule (50) every morning. Dosage schedules will be flexible. If needed for tic suppression, the dose will be increased weekly by 50 mg and given in BID doses. The maximum dose will be 200 mg/day (administered as 2 capsules BID). In any individual subject, dose escalation may proceed more slowly, or the dose may be reduced if necessary. At the 4 week visit, if an additional dosage increase is prescribed by Dr Singer, the pharmacy will provide an additional vial of 14 capsules labeled as study drug, but containing placebo capsules. No changes in dosage will be made during the final week of treatment.
|
Placebo
n=5 Participants
12 subjects age 8-17 years with moderate to severe TS (TTS \> 22) will be enrolled in this treatment arm. They will receive placebo for 6-weeks of the study, during which time drug dose may gradually be increased as needed. At 6-weeks participants will taper off drug.
Placebo: Placebo tablets will be formulated in look-alike capsules. At the 4 week visit, if an additional dosage increase is prescribed by Dr Singer, the pharmacy will provide an additional vial of 14 capsules labeled as study drug, but containing additional placebo capsules.
|
|---|---|---|---|
|
The Change From Baseline to 6-week Score for the Clinical Global Impression -Improvement (CGI-I).
|
0.78 units on a scale
Standard Error 0.83
|
1.70 units on a scale
Standard Error 0.67
|
1 units on a scale
Standard Error 1
|
SECONDARY outcome
Timeframe: Baseline and 6 weeksPatient Global Impression of Improvement (PGI-I) is a single seven point scale in which the patient/parent is asked to assess the change in overall condition ranging from "very much" improved to "very much worse." A score of 1 corresponds to "very much better"; 2 equals "much better;" 3 denotes "a little better"; and 4 represents "no change." Scores above 4 are used to indicate deterioration, i.e., 5 equals "a little worse;" 6 is "much worse;" and 7 is "very much worse." The data provided below represents the mean change (baseline minus six week) for the D-serine group (n = 9), Riluzole (n = 10), and Placebo group (n = 5). For consistency, all values weather positive or negative represent baseline minus week 6. Please note that only summary data (mean and standard deviation per group) were intended to be reported, and not participant level data (i.e. each individual data point of every subject per group)--this applies to all outcome measures reported in the results.
Outcome measures
| Measure |
D-serine (Glutamate Agonist)
n=9 Participants
24 subjects age 8-17 years with moderate to severe TS (TTS \> 22) will be enrolled in this treatment arm. They will receive D-serine for 6-weeks of the study, during which time drug dose may gradually be increased as needed. At 6-weeks participants will taper off drug.
D-serine: The dosage schedule will be flexible with a maximum dose for each subject being 30 mg/kg/day. In any individual subject, dose escalation may proceed more slowly, or the dose may be reduced if necessary. At the 4 week visit, if an additional dosage increase is prescribed by Dr Singer, the pharmacy will provide an additional vial of capsules labeled as study drug, but containing either 250 or 500 mg tablets of D-serine or placebo; capsule content to be determined by patient's weight. No changes in dosage will be made during the final week of treatment.
|
Riluzole (Glutamate Antagonist)
n=10 Participants
24 subjects age 8-17 years with moderate to severe TS (TTS \> 22) will be enrolled in this treatment arm. They will receive riluzole for 6-weeks of the study, during which time drug dose may gradually be increased as needed. At 6-weeks participants will taper off drug.
Riluzole: The starting dose of riluzole will be 50 mg for one week; administered as one capsule (50) every morning. Dosage schedules will be flexible. If needed for tic suppression, the dose will be increased weekly by 50 mg and given in BID doses. The maximum dose will be 200 mg/day (administered as 2 capsules BID). In any individual subject, dose escalation may proceed more slowly, or the dose may be reduced if necessary. At the 4 week visit, if an additional dosage increase is prescribed by Dr Singer, the pharmacy will provide an additional vial of 14 capsules labeled as study drug, but containing placebo capsules. No changes in dosage will be made during the final week of treatment.
|
Placebo
n=5 Participants
12 subjects age 8-17 years with moderate to severe TS (TTS \> 22) will be enrolled in this treatment arm. They will receive placebo for 6-weeks of the study, during which time drug dose may gradually be increased as needed. At 6-weeks participants will taper off drug.
Placebo: Placebo tablets will be formulated in look-alike capsules. At the 4 week visit, if an additional dosage increase is prescribed by Dr Singer, the pharmacy will provide an additional vial of 14 capsules labeled as study drug, but containing additional placebo capsules.
|
|---|---|---|---|
|
The Change From Baseline to 6-week Score for the Patient Global Impression of Improvement (PGI-I).
|
-0.56 units on a scale
Standard Error 0.88
|
-0.10 units on a scale
Standard Error 0.88
|
0.60 units on a scale
Standard Error 1.14
|
SECONDARY outcome
Timeframe: Baseline and 6-weeksSecondary outcome for obsessive-compulsive behaviors will be measured by changes in the Children's Yale-Brown Obsessive-Compulsive Scale (CY-BOCS) from baseline to 6-weeks. The severity of OCD was evaluated using either the Child Yale-Brown Obsessive Compulsive Scale (CY-BOCS) or Yale-Brown Obsessive Compulsive Scale (Y-BOCS). The (C)Y-BOCS is the most widely used instrument to assess the severity of obsessive-compulsive symptoms in research studies involving children. The (C)Y-BOCS has well established psychometric properties. The scale ranges from 0 (the best possible outcome) to 10 (the worst possible outcome). The data provided below represents the mean change (baseline minus six week) for the D-serine group (n = 9), Riluzole (n = 10), and Placebo group (n = 5). For consistency, all values weather positive or negative represent baseline minus week 6.
Outcome measures
| Measure |
D-serine (Glutamate Agonist)
n=9 Participants
24 subjects age 8-17 years with moderate to severe TS (TTS \> 22) will be enrolled in this treatment arm. They will receive D-serine for 6-weeks of the study, during which time drug dose may gradually be increased as needed. At 6-weeks participants will taper off drug.
D-serine: The dosage schedule will be flexible with a maximum dose for each subject being 30 mg/kg/day. In any individual subject, dose escalation may proceed more slowly, or the dose may be reduced if necessary. At the 4 week visit, if an additional dosage increase is prescribed by Dr Singer, the pharmacy will provide an additional vial of capsules labeled as study drug, but containing either 250 or 500 mg tablets of D-serine or placebo; capsule content to be determined by patient's weight. No changes in dosage will be made during the final week of treatment.
|
Riluzole (Glutamate Antagonist)
n=10 Participants
24 subjects age 8-17 years with moderate to severe TS (TTS \> 22) will be enrolled in this treatment arm. They will receive riluzole for 6-weeks of the study, during which time drug dose may gradually be increased as needed. At 6-weeks participants will taper off drug.
Riluzole: The starting dose of riluzole will be 50 mg for one week; administered as one capsule (50) every morning. Dosage schedules will be flexible. If needed for tic suppression, the dose will be increased weekly by 50 mg and given in BID doses. The maximum dose will be 200 mg/day (administered as 2 capsules BID). In any individual subject, dose escalation may proceed more slowly, or the dose may be reduced if necessary. At the 4 week visit, if an additional dosage increase is prescribed by Dr Singer, the pharmacy will provide an additional vial of 14 capsules labeled as study drug, but containing placebo capsules. No changes in dosage will be made during the final week of treatment.
|
Placebo
n=5 Participants
12 subjects age 8-17 years with moderate to severe TS (TTS \> 22) will be enrolled in this treatment arm. They will receive placebo for 6-weeks of the study, during which time drug dose may gradually be increased as needed. At 6-weeks participants will taper off drug.
Placebo: Placebo tablets will be formulated in look-alike capsules. At the 4 week visit, if an additional dosage increase is prescribed by Dr Singer, the pharmacy will provide an additional vial of 14 capsules labeled as study drug, but containing additional placebo capsules.
|
|---|---|---|---|
|
Changes in the Children's Yale-Brown Obsessive-Compulsive Scale (CY-BOCS) From Baseline to 6-weeks.
|
5.9 units on a scale
Standard Error 6.0
|
1.8 units on a scale
Standard Error 5.8
|
-0.8 units on a scale
Standard Error 4.0
|
SECONDARY outcome
Timeframe: Baseline and 6 weeks.Blood testing was performed at baseline and at each clinic visit. Data shown below reflects baseline Glutamic Acid minus Week 6 Glutamic Acid, and baseline Serine minus Week 6 Serine levels; as acquired from the blood tests during these respective clinic visits.
Outcome measures
| Measure |
D-serine (Glutamate Agonist)
n=9 Participants
24 subjects age 8-17 years with moderate to severe TS (TTS \> 22) will be enrolled in this treatment arm. They will receive D-serine for 6-weeks of the study, during which time drug dose may gradually be increased as needed. At 6-weeks participants will taper off drug.
D-serine: The dosage schedule will be flexible with a maximum dose for each subject being 30 mg/kg/day. In any individual subject, dose escalation may proceed more slowly, or the dose may be reduced if necessary. At the 4 week visit, if an additional dosage increase is prescribed by Dr Singer, the pharmacy will provide an additional vial of capsules labeled as study drug, but containing either 250 or 500 mg tablets of D-serine or placebo; capsule content to be determined by patient's weight. No changes in dosage will be made during the final week of treatment.
|
Riluzole (Glutamate Antagonist)
n=10 Participants
24 subjects age 8-17 years with moderate to severe TS (TTS \> 22) will be enrolled in this treatment arm. They will receive riluzole for 6-weeks of the study, during which time drug dose may gradually be increased as needed. At 6-weeks participants will taper off drug.
Riluzole: The starting dose of riluzole will be 50 mg for one week; administered as one capsule (50) every morning. Dosage schedules will be flexible. If needed for tic suppression, the dose will be increased weekly by 50 mg and given in BID doses. The maximum dose will be 200 mg/day (administered as 2 capsules BID). In any individual subject, dose escalation may proceed more slowly, or the dose may be reduced if necessary. At the 4 week visit, if an additional dosage increase is prescribed by Dr Singer, the pharmacy will provide an additional vial of 14 capsules labeled as study drug, but containing placebo capsules. No changes in dosage will be made during the final week of treatment.
|
Placebo
n=5 Participants
12 subjects age 8-17 years with moderate to severe TS (TTS \> 22) will be enrolled in this treatment arm. They will receive placebo for 6-weeks of the study, during which time drug dose may gradually be increased as needed. At 6-weeks participants will taper off drug.
Placebo: Placebo tablets will be formulated in look-alike capsules. At the 4 week visit, if an additional dosage increase is prescribed by Dr Singer, the pharmacy will provide an additional vial of 14 capsules labeled as study drug, but containing additional placebo capsules.
|
|---|---|---|---|
|
The Change From Baseline to 6-week in Plasma Amino Acid Levels
Baseline Serine Minus Week6 Serine
|
-108.22 micromol/L
Standard Deviation 69.38
|
13.30 micromol/L
Standard Deviation 30.29
|
-4.40 micromol/L
Standard Deviation 25.21
|
|
The Change From Baseline to 6-week in Plasma Amino Acid Levels
Baseline Glutamic Acid Minus Week6 Glutamic Acid
|
1.56 micromol/L
Standard Deviation 30.55
|
23.20 micromol/L
Standard Deviation 39.07
|
10.20 micromol/L
Standard Deviation 22.88
|
SECONDARY outcome
Timeframe: Baseline and 6 weeksPopulation: Please note that one subject failed to complete this assessment on week 6; therefore, the total number of participants in the placebo group for DuPaul ADHD is 4.
DuPaul ADHD Rating Scale: The presence of ADHD symptoms will be assessed using the DSM-IV version of the ADHD rating scale developed by DuPaul. This scale has been normed in large clinical and community samples and has excellent psychometric properties including a test-retest reliability over a 2-week period of 0.93 and significant correlations with direct observations of classroom behavior. The scale has a maximum possible score of 72, and a minimum of 0. The scale ranges from 0 (the best possible outcome) to 70 (the worst possible outcome). The data provided below represents the mean change (baseline minus six week) for the D-serine group (n = 9), Riluzole (n = 10), and Placebo group (n = 5). For consistency, all values weather positive or negative represent baseline minus week 6.
Outcome measures
| Measure |
D-serine (Glutamate Agonist)
n=9 Participants
24 subjects age 8-17 years with moderate to severe TS (TTS \> 22) will be enrolled in this treatment arm. They will receive D-serine for 6-weeks of the study, during which time drug dose may gradually be increased as needed. At 6-weeks participants will taper off drug.
D-serine: The dosage schedule will be flexible with a maximum dose for each subject being 30 mg/kg/day. In any individual subject, dose escalation may proceed more slowly, or the dose may be reduced if necessary. At the 4 week visit, if an additional dosage increase is prescribed by Dr Singer, the pharmacy will provide an additional vial of capsules labeled as study drug, but containing either 250 or 500 mg tablets of D-serine or placebo; capsule content to be determined by patient's weight. No changes in dosage will be made during the final week of treatment.
|
Riluzole (Glutamate Antagonist)
n=10 Participants
24 subjects age 8-17 years with moderate to severe TS (TTS \> 22) will be enrolled in this treatment arm. They will receive riluzole for 6-weeks of the study, during which time drug dose may gradually be increased as needed. At 6-weeks participants will taper off drug.
Riluzole: The starting dose of riluzole will be 50 mg for one week; administered as one capsule (50) every morning. Dosage schedules will be flexible. If needed for tic suppression, the dose will be increased weekly by 50 mg and given in BID doses. The maximum dose will be 200 mg/day (administered as 2 capsules BID). In any individual subject, dose escalation may proceed more slowly, or the dose may be reduced if necessary. At the 4 week visit, if an additional dosage increase is prescribed by Dr Singer, the pharmacy will provide an additional vial of 14 capsules labeled as study drug, but containing placebo capsules. No changes in dosage will be made during the final week of treatment.
|
Placebo
n=4 Participants
12 subjects age 8-17 years with moderate to severe TS (TTS \> 22) will be enrolled in this treatment arm. They will receive placebo for 6-weeks of the study, during which time drug dose may gradually be increased as needed. At 6-weeks participants will taper off drug.
Placebo: Placebo tablets will be formulated in look-alike capsules. At the 4 week visit, if an additional dosage increase is prescribed by Dr Singer, the pharmacy will provide an additional vial of 14 capsules labeled as study drug, but containing additional placebo capsules.
|
|---|---|---|---|
|
The Change From Baseline to 6-week in Scores of the DuPaul Attention Deficit Hyperactivity Disorder Rating Scale.
|
4.56 units on a scale
Standard Deviation 12.17
|
5.10 units on a scale
Standard Deviation 10.05
|
-7.00 units on a scale
Standard Deviation 4.39
|
SECONDARY outcome
Timeframe: Baseline and 6-weeksPopulation: Please note that two subjects failed to complete this assessment on week 6; therefore, the total number of participants in the placebo group for CDI-S is 3.
Depression Inventory-Short Version (DI-S): Depression severity will be rated by using the Depression Inventory-Short Version (DI-S). This 10 item scale takes about 5 minutes to complete. It has excellent psychometric properties and is designed for repeated administrations over time. The maximum possible score of 20, and a minimum score of 0. Higher score on this scale indicates greater severity of depression in children. The data provided below represents the mean change (baseline minus six week) for the D-serine group (n = 9), Riluzole (n = 10), and Placebo group (n = 3). For consistency, all values weather positive or negative represent baseline minus week 6.
Outcome measures
| Measure |
D-serine (Glutamate Agonist)
n=9 Participants
24 subjects age 8-17 years with moderate to severe TS (TTS \> 22) will be enrolled in this treatment arm. They will receive D-serine for 6-weeks of the study, during which time drug dose may gradually be increased as needed. At 6-weeks participants will taper off drug.
D-serine: The dosage schedule will be flexible with a maximum dose for each subject being 30 mg/kg/day. In any individual subject, dose escalation may proceed more slowly, or the dose may be reduced if necessary. At the 4 week visit, if an additional dosage increase is prescribed by Dr Singer, the pharmacy will provide an additional vial of capsules labeled as study drug, but containing either 250 or 500 mg tablets of D-serine or placebo; capsule content to be determined by patient's weight. No changes in dosage will be made during the final week of treatment.
|
Riluzole (Glutamate Antagonist)
n=10 Participants
24 subjects age 8-17 years with moderate to severe TS (TTS \> 22) will be enrolled in this treatment arm. They will receive riluzole for 6-weeks of the study, during which time drug dose may gradually be increased as needed. At 6-weeks participants will taper off drug.
Riluzole: The starting dose of riluzole will be 50 mg for one week; administered as one capsule (50) every morning. Dosage schedules will be flexible. If needed for tic suppression, the dose will be increased weekly by 50 mg and given in BID doses. The maximum dose will be 200 mg/day (administered as 2 capsules BID). In any individual subject, dose escalation may proceed more slowly, or the dose may be reduced if necessary. At the 4 week visit, if an additional dosage increase is prescribed by Dr Singer, the pharmacy will provide an additional vial of 14 capsules labeled as study drug, but containing placebo capsules. No changes in dosage will be made during the final week of treatment.
|
Placebo
n=3 Participants
12 subjects age 8-17 years with moderate to severe TS (TTS \> 22) will be enrolled in this treatment arm. They will receive placebo for 6-weeks of the study, during which time drug dose may gradually be increased as needed. At 6-weeks participants will taper off drug.
Placebo: Placebo tablets will be formulated in look-alike capsules. At the 4 week visit, if an additional dosage increase is prescribed by Dr Singer, the pharmacy will provide an additional vial of 14 capsules labeled as study drug, but containing additional placebo capsules.
|
|---|---|---|---|
|
The Change From Baseline to 6-week in Scores of the Child Depression Inventory - Short Version (CDI-S) Scale
|
0 units on a scale
Standard Error 3.0
|
-0.1 units on a scale
Standard Error 0.9
|
1.0 units on a scale
Standard Error 2.6
|
SECONDARY outcome
Timeframe: Baseline and 6-weeksPopulation: Please note that one subject failed to complete this assessment on week 6; therefore, the total number of participants in the placebo group for MASC is 4.
Multidimensional Anxiety Scale (MAS): Anxiety will be followed using the Multidimensional Anxiety Scale for Children (MASC), which has been developed by Dr. John March at Duke University and is now considered the preferred instrument for rating anxiety. The MASC asks the patient how they have been thinking and acting recently. It has a maximum possible score of 117 and a minimum score of 0. Higher score on this scale indicates greater severity of anxiety in children. The data provided below represents the mean change (baseline minus six week) for the D-serine group (n = 9), Riluzole (n = 10), and Placebo group (n = 5). For consistency, all values weather positive or negative represent baseline minus week 6.
Outcome measures
| Measure |
D-serine (Glutamate Agonist)
n=9 Participants
24 subjects age 8-17 years with moderate to severe TS (TTS \> 22) will be enrolled in this treatment arm. They will receive D-serine for 6-weeks of the study, during which time drug dose may gradually be increased as needed. At 6-weeks participants will taper off drug.
D-serine: The dosage schedule will be flexible with a maximum dose for each subject being 30 mg/kg/day. In any individual subject, dose escalation may proceed more slowly, or the dose may be reduced if necessary. At the 4 week visit, if an additional dosage increase is prescribed by Dr Singer, the pharmacy will provide an additional vial of capsules labeled as study drug, but containing either 250 or 500 mg tablets of D-serine or placebo; capsule content to be determined by patient's weight. No changes in dosage will be made during the final week of treatment.
|
Riluzole (Glutamate Antagonist)
n=10 Participants
24 subjects age 8-17 years with moderate to severe TS (TTS \> 22) will be enrolled in this treatment arm. They will receive riluzole for 6-weeks of the study, during which time drug dose may gradually be increased as needed. At 6-weeks participants will taper off drug.
Riluzole: The starting dose of riluzole will be 50 mg for one week; administered as one capsule (50) every morning. Dosage schedules will be flexible. If needed for tic suppression, the dose will be increased weekly by 50 mg and given in BID doses. The maximum dose will be 200 mg/day (administered as 2 capsules BID). In any individual subject, dose escalation may proceed more slowly, or the dose may be reduced if necessary. At the 4 week visit, if an additional dosage increase is prescribed by Dr Singer, the pharmacy will provide an additional vial of 14 capsules labeled as study drug, but containing placebo capsules. No changes in dosage will be made during the final week of treatment.
|
Placebo
n=4 Participants
12 subjects age 8-17 years with moderate to severe TS (TTS \> 22) will be enrolled in this treatment arm. They will receive placebo for 6-weeks of the study, during which time drug dose may gradually be increased as needed. At 6-weeks participants will taper off drug.
Placebo: Placebo tablets will be formulated in look-alike capsules. At the 4 week visit, if an additional dosage increase is prescribed by Dr Singer, the pharmacy will provide an additional vial of 14 capsules labeled as study drug, but containing additional placebo capsules.
|
|---|---|---|---|
|
The Change From Baseline to 6-week in Scores of the Multi-Dimensional Anxiety Scale for Children (MASC)
|
1.33 units on a scale
Standard Deviation 14.44
|
-3.30 units on a scale
Standard Deviation 6.98
|
6.25 units on a scale
Standard Deviation 6.28
|
SECONDARY outcome
Timeframe: BaselineThe scale consists of 25 items with a score of 0 to 3 per item. 0- none, 1- mild, 2- moderate and 3- severe side effect. The total could be zero (no side effects) to 75 or higher.The scale also allows for the addition of other side effects not included in the original scale and the total score could potentially be higher than 75. If no other side effects outside of the original scale are recorded, the the maximum score remains at 75.
Outcome measures
| Measure |
D-serine (Glutamate Agonist)
n=9 Participants
24 subjects age 8-17 years with moderate to severe TS (TTS \> 22) will be enrolled in this treatment arm. They will receive D-serine for 6-weeks of the study, during which time drug dose may gradually be increased as needed. At 6-weeks participants will taper off drug.
D-serine: The dosage schedule will be flexible with a maximum dose for each subject being 30 mg/kg/day. In any individual subject, dose escalation may proceed more slowly, or the dose may be reduced if necessary. At the 4 week visit, if an additional dosage increase is prescribed by Dr Singer, the pharmacy will provide an additional vial of capsules labeled as study drug, but containing either 250 or 500 mg tablets of D-serine or placebo; capsule content to be determined by patient's weight. No changes in dosage will be made during the final week of treatment.
|
Riluzole (Glutamate Antagonist)
n=10 Participants
24 subjects age 8-17 years with moderate to severe TS (TTS \> 22) will be enrolled in this treatment arm. They will receive riluzole for 6-weeks of the study, during which time drug dose may gradually be increased as needed. At 6-weeks participants will taper off drug.
Riluzole: The starting dose of riluzole will be 50 mg for one week; administered as one capsule (50) every morning. Dosage schedules will be flexible. If needed for tic suppression, the dose will be increased weekly by 50 mg and given in BID doses. The maximum dose will be 200 mg/day (administered as 2 capsules BID). In any individual subject, dose escalation may proceed more slowly, or the dose may be reduced if necessary. At the 4 week visit, if an additional dosage increase is prescribed by Dr Singer, the pharmacy will provide an additional vial of 14 capsules labeled as study drug, but containing placebo capsules. No changes in dosage will be made during the final week of treatment.
|
Placebo
n=5 Participants
12 subjects age 8-17 years with moderate to severe TS (TTS \> 22) will be enrolled in this treatment arm. They will receive placebo for 6-weeks of the study, during which time drug dose may gradually be increased as needed. At 6-weeks participants will taper off drug.
Placebo: Placebo tablets will be formulated in look-alike capsules. At the 4 week visit, if an additional dosage increase is prescribed by Dr Singer, the pharmacy will provide an additional vial of 14 capsules labeled as study drug, but containing additional placebo capsules.
|
|---|---|---|---|
|
Expanded Pittsburgh Side Effect Scale Modified to Include Side Effects of Riluzole and D-serine.
|
0.56 units on a scale
Interval 0.0 to 75.0
|
0.5 units on a scale
Interval 0.0 to 75.0
|
0.2 units on a scale
Interval 0.0 to 75.0
|
SECONDARY outcome
Timeframe: Week 2The scale consists of 25 items with a score of 0 to 3 per item. 0- none, 1- mild, 2- moderate and 3- severe side effect. The total could be zero (no side effects) to 75 or higher.The scale also allows for the addition of other side effects not included in the original scale and the total score could potentially be higher than 75. If no other side effects outside of the original scale are recorded, the the maximum score remains at 75.
Outcome measures
| Measure |
D-serine (Glutamate Agonist)
n=9 Participants
24 subjects age 8-17 years with moderate to severe TS (TTS \> 22) will be enrolled in this treatment arm. They will receive D-serine for 6-weeks of the study, during which time drug dose may gradually be increased as needed. At 6-weeks participants will taper off drug.
D-serine: The dosage schedule will be flexible with a maximum dose for each subject being 30 mg/kg/day. In any individual subject, dose escalation may proceed more slowly, or the dose may be reduced if necessary. At the 4 week visit, if an additional dosage increase is prescribed by Dr Singer, the pharmacy will provide an additional vial of capsules labeled as study drug, but containing either 250 or 500 mg tablets of D-serine or placebo; capsule content to be determined by patient's weight. No changes in dosage will be made during the final week of treatment.
|
Riluzole (Glutamate Antagonist)
n=10 Participants
24 subjects age 8-17 years with moderate to severe TS (TTS \> 22) will be enrolled in this treatment arm. They will receive riluzole for 6-weeks of the study, during which time drug dose may gradually be increased as needed. At 6-weeks participants will taper off drug.
Riluzole: The starting dose of riluzole will be 50 mg for one week; administered as one capsule (50) every morning. Dosage schedules will be flexible. If needed for tic suppression, the dose will be increased weekly by 50 mg and given in BID doses. The maximum dose will be 200 mg/day (administered as 2 capsules BID). In any individual subject, dose escalation may proceed more slowly, or the dose may be reduced if necessary. At the 4 week visit, if an additional dosage increase is prescribed by Dr Singer, the pharmacy will provide an additional vial of 14 capsules labeled as study drug, but containing placebo capsules. No changes in dosage will be made during the final week of treatment.
|
Placebo
n=5 Participants
12 subjects age 8-17 years with moderate to severe TS (TTS \> 22) will be enrolled in this treatment arm. They will receive placebo for 6-weeks of the study, during which time drug dose may gradually be increased as needed. At 6-weeks participants will taper off drug.
Placebo: Placebo tablets will be formulated in look-alike capsules. At the 4 week visit, if an additional dosage increase is prescribed by Dr Singer, the pharmacy will provide an additional vial of 14 capsules labeled as study drug, but containing additional placebo capsules.
|
|---|---|---|---|
|
Expanded Pittsburgh Side Effect Scale Modified to Include Side Effects of Riluzole and D-serine.
|
0.33 units on a scale
Interval 0.0 to 75.0
|
0 units on a scale
Interval 0.0 to 75.0
|
0 units on a scale
Interval 0.0 to 75.0
|
SECONDARY outcome
Timeframe: Week 4The scale consists of 25 items with a score of 0 to 3 per item. 0- none, 1- mild, 2- moderate and 3- severe side effect. The total could be zero (no side effects) to 75 or higher.The scale also allows for the addition of other side effects not included in the original scale and the total score could potentially be higher than 75. If no other side effects outside of the original scale are recorded, the the maximum score remains at 75.
Outcome measures
| Measure |
D-serine (Glutamate Agonist)
n=9 Participants
24 subjects age 8-17 years with moderate to severe TS (TTS \> 22) will be enrolled in this treatment arm. They will receive D-serine for 6-weeks of the study, during which time drug dose may gradually be increased as needed. At 6-weeks participants will taper off drug.
D-serine: The dosage schedule will be flexible with a maximum dose for each subject being 30 mg/kg/day. In any individual subject, dose escalation may proceed more slowly, or the dose may be reduced if necessary. At the 4 week visit, if an additional dosage increase is prescribed by Dr Singer, the pharmacy will provide an additional vial of capsules labeled as study drug, but containing either 250 or 500 mg tablets of D-serine or placebo; capsule content to be determined by patient's weight. No changes in dosage will be made during the final week of treatment.
|
Riluzole (Glutamate Antagonist)
n=10 Participants
24 subjects age 8-17 years with moderate to severe TS (TTS \> 22) will be enrolled in this treatment arm. They will receive riluzole for 6-weeks of the study, during which time drug dose may gradually be increased as needed. At 6-weeks participants will taper off drug.
Riluzole: The starting dose of riluzole will be 50 mg for one week; administered as one capsule (50) every morning. Dosage schedules will be flexible. If needed for tic suppression, the dose will be increased weekly by 50 mg and given in BID doses. The maximum dose will be 200 mg/day (administered as 2 capsules BID). In any individual subject, dose escalation may proceed more slowly, or the dose may be reduced if necessary. At the 4 week visit, if an additional dosage increase is prescribed by Dr Singer, the pharmacy will provide an additional vial of 14 capsules labeled as study drug, but containing placebo capsules. No changes in dosage will be made during the final week of treatment.
|
Placebo
n=5 Participants
12 subjects age 8-17 years with moderate to severe TS (TTS \> 22) will be enrolled in this treatment arm. They will receive placebo for 6-weeks of the study, during which time drug dose may gradually be increased as needed. At 6-weeks participants will taper off drug.
Placebo: Placebo tablets will be formulated in look-alike capsules. At the 4 week visit, if an additional dosage increase is prescribed by Dr Singer, the pharmacy will provide an additional vial of 14 capsules labeled as study drug, but containing additional placebo capsules.
|
|---|---|---|---|
|
Expanded Pittsburgh Side Effect Scale Modified to Include Side Effects of Riluzole and D-serine.
|
0.22 units on a scale
Interval 0.0 to 75.0
|
0.5 units on a scale
Interval 0.0 to 75.0
|
0.25 units on a scale
Interval 0.0 to 75.0
|
SECONDARY outcome
Timeframe: Week 6The scale consists of 25 items with a score of 0 to 3 per item. 0- none, 1- mild, 2- moderate and 3- severe side effect. The total could be zero (no side effects) to 75 or higher.The scale also allows for the addition of other side effects not included in the original scale and the total score could potentially be higher than 75. If no other side effects outside of the original scale are recorded, the the maximum score remains at 75.
Outcome measures
| Measure |
D-serine (Glutamate Agonist)
n=9 Participants
24 subjects age 8-17 years with moderate to severe TS (TTS \> 22) will be enrolled in this treatment arm. They will receive D-serine for 6-weeks of the study, during which time drug dose may gradually be increased as needed. At 6-weeks participants will taper off drug.
D-serine: The dosage schedule will be flexible with a maximum dose for each subject being 30 mg/kg/day. In any individual subject, dose escalation may proceed more slowly, or the dose may be reduced if necessary. At the 4 week visit, if an additional dosage increase is prescribed by Dr Singer, the pharmacy will provide an additional vial of capsules labeled as study drug, but containing either 250 or 500 mg tablets of D-serine or placebo; capsule content to be determined by patient's weight. No changes in dosage will be made during the final week of treatment.
|
Riluzole (Glutamate Antagonist)
n=10 Participants
24 subjects age 8-17 years with moderate to severe TS (TTS \> 22) will be enrolled in this treatment arm. They will receive riluzole for 6-weeks of the study, during which time drug dose may gradually be increased as needed. At 6-weeks participants will taper off drug.
Riluzole: The starting dose of riluzole will be 50 mg for one week; administered as one capsule (50) every morning. Dosage schedules will be flexible. If needed for tic suppression, the dose will be increased weekly by 50 mg and given in BID doses. The maximum dose will be 200 mg/day (administered as 2 capsules BID). In any individual subject, dose escalation may proceed more slowly, or the dose may be reduced if necessary. At the 4 week visit, if an additional dosage increase is prescribed by Dr Singer, the pharmacy will provide an additional vial of 14 capsules labeled as study drug, but containing placebo capsules. No changes in dosage will be made during the final week of treatment.
|
Placebo
n=5 Participants
12 subjects age 8-17 years with moderate to severe TS (TTS \> 22) will be enrolled in this treatment arm. They will receive placebo for 6-weeks of the study, during which time drug dose may gradually be increased as needed. At 6-weeks participants will taper off drug.
Placebo: Placebo tablets will be formulated in look-alike capsules. At the 4 week visit, if an additional dosage increase is prescribed by Dr Singer, the pharmacy will provide an additional vial of 14 capsules labeled as study drug, but containing additional placebo capsules.
|
|---|---|---|---|
|
Expanded Pittsburgh Side Effect Scale Modified to Include Side Effects of Riluzole and D-serine.
|
0.44 units on a scale
Interval 0.0 to 75.0
|
0.5 units on a scale
Interval 0.0 to 75.0
|
0.5 units on a scale
Interval 0.0 to 75.0
|
SECONDARY outcome
Timeframe: Week 8The scale consists of 25 items with a score of 0 to 3 per item. 0- none, 1- mild, 2- moderate and 3- severe side effect. The total could be zero (no side effects) to 75 or higher.The scale also allows for the addition of other side effects not included in the original scale and the total score could potentially be higher than 75. If no other side effects outside of the original scale are recorded, the the maximum score remains at 75.
Outcome measures
| Measure |
D-serine (Glutamate Agonist)
n=9 Participants
24 subjects age 8-17 years with moderate to severe TS (TTS \> 22) will be enrolled in this treatment arm. They will receive D-serine for 6-weeks of the study, during which time drug dose may gradually be increased as needed. At 6-weeks participants will taper off drug.
D-serine: The dosage schedule will be flexible with a maximum dose for each subject being 30 mg/kg/day. In any individual subject, dose escalation may proceed more slowly, or the dose may be reduced if necessary. At the 4 week visit, if an additional dosage increase is prescribed by Dr Singer, the pharmacy will provide an additional vial of capsules labeled as study drug, but containing either 250 or 500 mg tablets of D-serine or placebo; capsule content to be determined by patient's weight. No changes in dosage will be made during the final week of treatment.
|
Riluzole (Glutamate Antagonist)
n=10 Participants
24 subjects age 8-17 years with moderate to severe TS (TTS \> 22) will be enrolled in this treatment arm. They will receive riluzole for 6-weeks of the study, during which time drug dose may gradually be increased as needed. At 6-weeks participants will taper off drug.
Riluzole: The starting dose of riluzole will be 50 mg for one week; administered as one capsule (50) every morning. Dosage schedules will be flexible. If needed for tic suppression, the dose will be increased weekly by 50 mg and given in BID doses. The maximum dose will be 200 mg/day (administered as 2 capsules BID). In any individual subject, dose escalation may proceed more slowly, or the dose may be reduced if necessary. At the 4 week visit, if an additional dosage increase is prescribed by Dr Singer, the pharmacy will provide an additional vial of 14 capsules labeled as study drug, but containing placebo capsules. No changes in dosage will be made during the final week of treatment.
|
Placebo
n=5 Participants
12 subjects age 8-17 years with moderate to severe TS (TTS \> 22) will be enrolled in this treatment arm. They will receive placebo for 6-weeks of the study, during which time drug dose may gradually be increased as needed. At 6-weeks participants will taper off drug.
Placebo: Placebo tablets will be formulated in look-alike capsules. At the 4 week visit, if an additional dosage increase is prescribed by Dr Singer, the pharmacy will provide an additional vial of 14 capsules labeled as study drug, but containing additional placebo capsules.
|
|---|---|---|---|
|
Expanded Pittsburgh Side Effect Scale Modified to Include Side Effects of Riluzole and D-serine.
|
0.33 units on a scale
Interval 0.0 to 75.0
|
0.2 units on a scale
Interval 0.0 to 75.0
|
0.2 units on a scale
Interval 0.0 to 75.0
|
Adverse Events
D-serine (Glutamate Agonist)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Riluzole (Glutamate Antagonist)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Placebo
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place