Trial Outcomes & Findings for Study to Evaluate the Effect of AFQ056 in Obsessive Compulsive Disorder (OCD) Patients Resistant to Selective Serotonin Reuptake Inhibitor (SSRI) Therapy (NCT NCT01813019)
NCT ID: NCT01813019
Last Updated: 2017-01-02
Results Overview
The Y-BOCS is a 10 item clinician-rated scale used to both determine the severity of OCD and to monitor symptom improvement throughout the course of the study. The Y-BOCS, specifically measures the severity of symptoms of OCD without being biased towards the type of obsessions or compulsions present. The scale includes questions about the amount of time spent on, how much impairment or distress experienced from, and how much resistance and control over these obsessive thoughts and compulsions. Each item is rated from 0 ("no symptoms") to 4 ("extreme symptoms") and yields a total possible score range from 0 to 40, with the following ranges indicating degree of severity: 0-7 = sub-clinical 8-15 = mild 16-23 = moderate 24-31 = severe 32-40 = extreme Baseline was compared to week 17 (end of week 16 dosing) to produce an absolute change.
TERMINATED
PHASE2
50 participants
baseline, week 17
2017-01-02
Participant Flow
Participant milestones
| Measure |
Placebo
Matching Placebo b.i.d. dosing
|
AFQ056
AFQ056 b.i.d up-titration of 50mg,100mg, 150mg and 200 mg for 4 weeks then AFQ056 200mg b.i.d for 12 weeks and then a down-titration of AFQ056 100mg, 50mg and 25mg b.i.d for 3 weeks
|
|---|---|---|
|
Overall Study
STARTED
|
24
|
26
|
|
Overall Study
COMPLETED
|
17
|
20
|
|
Overall Study
NOT COMPLETED
|
7
|
6
|
Reasons for withdrawal
| Measure |
Placebo
Matching Placebo b.i.d. dosing
|
AFQ056
AFQ056 b.i.d up-titration of 50mg,100mg, 150mg and 200 mg for 4 weeks then AFQ056 200mg b.i.d for 12 weeks and then a down-titration of AFQ056 100mg, 50mg and 25mg b.i.d for 3 weeks
|
|---|---|---|
|
Overall Study
Adverse Event
|
0
|
3
|
|
Overall Study
Withdrawal by Subject
|
3
|
2
|
|
Overall Study
administrative problems
|
2
|
0
|
|
Overall Study
Protocol Deviation
|
2
|
1
|
Baseline Characteristics
Study to Evaluate the Effect of AFQ056 in Obsessive Compulsive Disorder (OCD) Patients Resistant to Selective Serotonin Reuptake Inhibitor (SSRI) Therapy
Baseline characteristics by cohort
| Measure |
Placebo
n=24 Participants
Matching Placebo b.i.d. dosing
|
AFQ056
n=26 Participants
AFQ056 b.i.d up-titration of 50mg,100mg, 150mg and 200 mg for 4 weeks then AFQ056 200mg b.i.d for 12 weeks and then a down-titration of AFQ056 100mg, 50mg and 25mg b.i.d for 3 weeks
|
Total
n=50 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
39.9 years
STANDARD_DEVIATION 10.06 • n=5 Participants
|
41.3 years
STANDARD_DEVIATION 13.27 • n=7 Participants
|
40.6 years
STANDARD_DEVIATION 11.74 • n=5 Participants
|
|
Gender
Female
|
13 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
26 Participants
n=5 Participants
|
|
Gender
Male
|
11 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
24 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: baseline, week 17Population: Pharmacodynamics (PD) analysis set only participants that were analyzed at baseline and Week 17. Positive change from baseline indicates a decrease in symptom severity
The Y-BOCS is a 10 item clinician-rated scale used to both determine the severity of OCD and to monitor symptom improvement throughout the course of the study. The Y-BOCS, specifically measures the severity of symptoms of OCD without being biased towards the type of obsessions or compulsions present. The scale includes questions about the amount of time spent on, how much impairment or distress experienced from, and how much resistance and control over these obsessive thoughts and compulsions. Each item is rated from 0 ("no symptoms") to 4 ("extreme symptoms") and yields a total possible score range from 0 to 40, with the following ranges indicating degree of severity: 0-7 = sub-clinical 8-15 = mild 16-23 = moderate 24-31 = severe 32-40 = extreme Baseline was compared to week 17 (end of week 16 dosing) to produce an absolute change.
Outcome measures
| Measure |
Placebo
n=17 Participants
Matching Placebo b.i.d. dosing
|
AFQ056
n=21 Participants
AFQ056 b.i.d up-titration of 50mg,100mg, 150mg and 200 mg for 4 weeks then AFQ056 200mg b.i.d for 12 weeks and then a down-titration of AFQ056 100mg, 50mg and 25mg b.i.d for 3 weeks
|
|---|---|---|
|
Yale - Brown Obsessive Compulsive Scale (Y-BOCS) Absolute Change From Baseline at Week 17 (End of 16-week Dosing).
|
-8.0 Scores on a scale
Standard Error 1.78
|
-6.9 Scores on a scale
Standard Error 1.75
|
SECONDARY outcome
Timeframe: 16 weeksPopulation: The study was terminated due to an interim analysis of the primary efficacy outcome. Study was prematurely terminated at the time of the first Interim Analysis (IA) as the study did not meet its primary efficacy objective therefore secondary objective was not measured.
If a subject demonstrates at least 25% reduction in total Y-BOCS from Baseline then they will be classed as a responder whereas if a subject has a reduction in Y-BOCS of less than 25% then they will be categorized as a nonresponder.
Outcome measures
Outcome data not reported
Adverse Events
Placebo
AFQ056
Serious adverse events
| Measure |
Placebo
n=24 participants at risk
Matching Placebo b.i.d. dosing
|
AFQ056
n=26 participants at risk
AFQ056 b.i.d up-titration of 50mg,100mg, 150mg and 200 mg for 4 weeks then AFQ056 200mg b.i.d for 12 weeks and then a down-titration of AFQ056 100mg, 50mg and 25mg b.i.d for 3 weeks
|
|---|---|---|
|
Cardiac disorders
Atrial fibrillation
|
4.2%
1/24
|
0.00%
0/26
|
|
Infections and infestations
Otitis media
|
0.00%
0/24
|
3.8%
1/26
|
|
Injury, poisoning and procedural complications
Face injury
|
4.2%
1/24
|
0.00%
0/26
|
|
Injury, poisoning and procedural complications
Head injury
|
4.2%
1/24
|
0.00%
0/26
|
|
Injury, poisoning and procedural complications
Limb injury
|
4.2%
1/24
|
0.00%
0/26
|
|
Nervous system disorders
VIIth nerve paralysis
|
0.00%
0/24
|
3.8%
1/26
|
Other adverse events
| Measure |
Placebo
n=24 participants at risk
Matching Placebo b.i.d. dosing
|
AFQ056
n=26 participants at risk
AFQ056 b.i.d up-titration of 50mg,100mg, 150mg and 200 mg for 4 weeks then AFQ056 200mg b.i.d for 12 weeks and then a down-titration of AFQ056 100mg, 50mg and 25mg b.i.d for 3 weeks
|
|---|---|---|
|
Cardiac disorders
Bradycardia
|
8.3%
2/24
|
0.00%
0/26
|
|
Ear and labyrinth disorders
Vertigo
|
4.2%
1/24
|
7.7%
2/26
|
|
Gastrointestinal disorders
Abdominal pain upper
|
4.2%
1/24
|
7.7%
2/26
|
|
Gastrointestinal disorders
Dyspepsia
|
0.00%
0/24
|
7.7%
2/26
|
|
General disorders
Fatigue
|
4.2%
1/24
|
7.7%
2/26
|
|
Infections and infestations
Nasopharyngitis
|
16.7%
4/24
|
7.7%
2/26
|
|
Investigations
Aspartate aminotransferase increased
|
4.2%
1/24
|
7.7%
2/26
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/24
|
7.7%
2/26
|
|
Nervous system disorders
Disturbance in attention
|
0.00%
0/24
|
7.7%
2/26
|
|
Nervous system disorders
Dizziness
|
8.3%
2/24
|
19.2%
5/26
|
|
Nervous system disorders
Headache
|
33.3%
8/24
|
38.5%
10/26
|
|
Nervous system disorders
Migraine
|
0.00%
0/24
|
7.7%
2/26
|
|
Psychiatric disorders
Abnormal dreams
|
4.2%
1/24
|
7.7%
2/26
|
|
Psychiatric disorders
Agitation
|
0.00%
0/24
|
7.7%
2/26
|
|
Psychiatric disorders
Depression
|
8.3%
2/24
|
3.8%
1/26
|
|
Psychiatric disorders
Insomnia
|
8.3%
2/24
|
23.1%
6/26
|
Additional Information
Study Director
Novartis Pharmaceuticals
Results disclosure agreements
- Principal investigator is a sponsor employee The terms and conditions of Novartis' agreements with its investigators may vary. However, Novartis does not prohibit any investigator from publishing. Any publications from a single-site are postponed until the publication of the pooled data (i.e., data from all sites) in the clinical trial or disclosure of trial results in their entirety.
- Publication restrictions are in place
Restriction type: OTHER