Trial Outcomes & Findings for A Pilot Trial of Lithium in Subjects With Progressive Supranuclear Palsy or Corticobasal Degeneration (NCT NCT00703677)
NCT ID: NCT00703677
Last Updated: 2024-05-17
Results Overview
The ability to complete the study period on lithium at a serum concentration of at least 0.4 mEq/L.
Recruitment status
COMPLETED
Study phase
PHASE1/PHASE2
Target enrollment
17 participants
Primary outcome timeframe
28 weeks
Results posted on
2024-05-17
Participant Flow
The protocol was open for recruitment between September 2008 and August 24, 2009 at neurology clinics affiliated with university hospitals.
Participant milestones
| Measure |
Lithium Carbonate
All participants will receive lithium in this open label study (single arm). Dosages will be determined in advance to achieve serum concentrations of 0.4-0.6, 0.6-0.8, 0.8-1.0, and 1.0-1.2 mEq/L.
|
|---|---|
|
Overall Study
STARTED
|
17
|
|
Overall Study
COMPLETED
|
14
|
|
Overall Study
NOT COMPLETED
|
3
|
Reasons for withdrawal
| Measure |
Lithium Carbonate
All participants will receive lithium in this open label study (single arm). Dosages will be determined in advance to achieve serum concentrations of 0.4-0.6, 0.6-0.8, 0.8-1.0, and 1.0-1.2 mEq/L.
|
|---|---|
|
Overall Study
Dropout-withdrawal not related to drug
|
3
|
Baseline Characteristics
A Pilot Trial of Lithium in Subjects With Progressive Supranuclear Palsy or Corticobasal Degeneration
Baseline characteristics by cohort
| Measure |
Lithium Carbonate
n=17 Participants
All participants will receive lithium in this open label study (single arm). Dosages will be determined in advance to achieve serum concentrations of 0.4-0.6, 0.6-0.8, 0.8-1.0, and 1.0-1.2 mEq/L.
|
|---|---|
|
Age, Customized
40 - 49 years
|
0 participants
n=5 Participants
|
|
Age, Customized
50 - 59 years
|
2 participants
n=5 Participants
|
|
Age, Customized
60 - 69 years
|
9 participants
n=5 Participants
|
|
Age, Customized
70 - 79 years
|
6 participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
8 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
9 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
16 participants
n=5 Participants
|
|
Region of Enrollment
United Kingdom
|
1 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 28 weeksPopulation: One subject completed the full 28 week course of study drug; 13 subjects stopped drug early due to intolerability.
The ability to complete the study period on lithium at a serum concentration of at least 0.4 mEq/L.
Outcome measures
| Measure |
Lithium Carbonate
n=14 Participants
All participants will receive lithium in this open label study (single arm). Dosages will be determined in advance to achieve serum concentrations of 0.4-0.6, 0.6-0.8, 0.8-1.0, and 1.0-1.2 mEq/L.
|
|---|---|
|
Ability to Tolerate Lithium Carbonate
|
1 Subject
|
SECONDARY outcome
Timeframe: 28 weeksPopulation: All subjects were evaluated for compliance.
Subjects receiving 80% or more of the prescribed doses between study visits were considered compliant.
Outcome measures
| Measure |
Lithium Carbonate
n=14 Participants
All participants will receive lithium in this open label study (single arm). Dosages will be determined in advance to achieve serum concentrations of 0.4-0.6, 0.6-0.8, 0.8-1.0, and 1.0-1.2 mEq/L.
|
|---|---|
|
Study Drug Compliance
|
14 Subjects
|
SECONDARY outcome
Timeframe: 28 weeksPopulation: Due to the very small number of samples collected, samples were not analyzed
Progressive supranuclear palsy (PSP) and corticobasal degeneration (CBD) are characterized by hyperphosphorylation of tau. Lithium inhibits one of the kinases (GSK-3 beta) that phosphorylates tau; levels of tau phosphorylation will be measured at baseline and at Week 28.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 28 weeksPopulation: Due to the very small number of samples collected, samples were not analyzed
With inhibition of Glycogen Synthase Kinase (GSK)-3 beta, levels of BDNF may increase. BDNF levels will be measured at baseline and at Week 28.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 28 weeksPopulation: Due to the very small number of samples collected, samples were not analyzed.
Levels of beta-catenin and the ratio of phosphorylated GSK-3 beta to total GSK-3 beta will be measured at baseline and at Week 28
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 28 weeksThe PSP Rating Scale is a 28-item scale designed to assess the disability associated with PSP. The six functional categories assessed are: daily activities, behavior, bulbar function, oculomotor function, limb motor function, and gait/midline function. Subjects will be assessed at baseline and Weeks 12, 20, and 28.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 28 weeksThe UPDRS is a commonly used clinical rating scale to assess motor function in patients with parkinsonism. Subjects will be assessed at baseline and Weeks 5, 12, 20, and 28.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 28 weeksThe PSP-QoL Scale is an instrument designed to assess mental and physical aspects of quality of life specifically in patients with PSP. Subjects will be assessed at baseline and Weeks 12, 20, and 28.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 28 weeksThe FAB is a brief, 6-item instrument designed to assess executive function. Subjects will be assessed at baseline and at Week 28.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 28 weeksThe GDS-15 is a 15-item instrument used to screen for depression in the elderly. Subjects will be assessed at the Screening Visit and at Week 28.
Outcome measures
Outcome data not reported
Adverse Events
Lithium Carbonate
Serious events: 4 serious events
Other events: 17 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Lithium Carbonate
n=17 participants at risk
All participants will receive lithium in this open label study (single arm). Dosages will be determined in advance to achieve serum concentrations of 0.4-0.6, 0.6-0.8, 0.8-1.0, and 1.0-1.2 mEq/L.
|
|---|---|
|
Gastrointestinal disorders
Intestinal obstruction
|
5.9%
1/17 • Number of events 1 • Data were collected over a 15 month period.
Data were collected at scheduled clinic and telephone study visits via medical history, physical examinations, laboratory tests, EKG, and other tests as necessary. In addition, adverse events were reported to site investigators by subjects and their study partners between visits, as needed.
|
|
Injury, poisoning and procedural complications
Fall
|
5.9%
1/17 • Number of events 1 • Data were collected over a 15 month period.
Data were collected at scheduled clinic and telephone study visits via medical history, physical examinations, laboratory tests, EKG, and other tests as necessary. In addition, adverse events were reported to site investigators by subjects and their study partners between visits, as needed.
|
|
Metabolism and nutrition disorders
Hypernatraemia
|
5.9%
1/17 • Number of events 1 • Data were collected over a 15 month period.
Data were collected at scheduled clinic and telephone study visits via medical history, physical examinations, laboratory tests, EKG, and other tests as necessary. In addition, adverse events were reported to site investigators by subjects and their study partners between visits, as needed.
|
|
Nervous system disorders
Balance disorder
|
5.9%
1/17 • Number of events 1 • Data were collected over a 15 month period.
Data were collected at scheduled clinic and telephone study visits via medical history, physical examinations, laboratory tests, EKG, and other tests as necessary. In addition, adverse events were reported to site investigators by subjects and their study partners between visits, as needed.
|
Other adverse events
| Measure |
Lithium Carbonate
n=17 participants at risk
All participants will receive lithium in this open label study (single arm). Dosages will be determined in advance to achieve serum concentrations of 0.4-0.6, 0.6-0.8, 0.8-1.0, and 1.0-1.2 mEq/L.
|
|---|---|
|
General disorders
Fatigue
|
29.4%
5/17 • Number of events 8 • Data were collected over a 15 month period.
Data were collected at scheduled clinic and telephone study visits via medical history, physical examinations, laboratory tests, EKG, and other tests as necessary. In addition, adverse events were reported to site investigators by subjects and their study partners between visits, as needed.
|
|
Eye disorders
Eyelid oedema
|
5.9%
1/17 • Number of events 1 • Data were collected over a 15 month period.
Data were collected at scheduled clinic and telephone study visits via medical history, physical examinations, laboratory tests, EKG, and other tests as necessary. In addition, adverse events were reported to site investigators by subjects and their study partners between visits, as needed.
|
|
Gastrointestinal disorders
Constipation
|
5.9%
1/17 • Number of events 1 • Data were collected over a 15 month period.
Data were collected at scheduled clinic and telephone study visits via medical history, physical examinations, laboratory tests, EKG, and other tests as necessary. In addition, adverse events were reported to site investigators by subjects and their study partners between visits, as needed.
|
|
Gastrointestinal disorders
Dyspepsia
|
5.9%
1/17 • Number of events 1 • Data were collected over a 15 month period.
Data were collected at scheduled clinic and telephone study visits via medical history, physical examinations, laboratory tests, EKG, and other tests as necessary. In addition, adverse events were reported to site investigators by subjects and their study partners between visits, as needed.
|
|
Gastrointestinal disorders
Dysphagia
|
11.8%
2/17 • Number of events 3 • Data were collected over a 15 month period.
Data were collected at scheduled clinic and telephone study visits via medical history, physical examinations, laboratory tests, EKG, and other tests as necessary. In addition, adverse events were reported to site investigators by subjects and their study partners between visits, as needed.
|
|
Gastrointestinal disorders
Nausea
|
5.9%
1/17 • Number of events 1 • Data were collected over a 15 month period.
Data were collected at scheduled clinic and telephone study visits via medical history, physical examinations, laboratory tests, EKG, and other tests as necessary. In addition, adverse events were reported to site investigators by subjects and their study partners between visits, as needed.
|
|
General disorders
Asthenia
|
23.5%
4/17 • Number of events 6 • Data were collected over a 15 month period.
Data were collected at scheduled clinic and telephone study visits via medical history, physical examinations, laboratory tests, EKG, and other tests as necessary. In addition, adverse events were reported to site investigators by subjects and their study partners between visits, as needed.
|
|
Nervous system disorders
Gait disturbance/Balance disorder
|
52.9%
9/17 • Number of events 16 • Data were collected over a 15 month period.
Data were collected at scheduled clinic and telephone study visits via medical history, physical examinations, laboratory tests, EKG, and other tests as necessary. In addition, adverse events were reported to site investigators by subjects and their study partners between visits, as needed.
|
|
General disorders
Oedema peripheral
|
5.9%
1/17 • Number of events 1 • Data were collected over a 15 month period.
Data were collected at scheduled clinic and telephone study visits via medical history, physical examinations, laboratory tests, EKG, and other tests as necessary. In addition, adverse events were reported to site investigators by subjects and their study partners between visits, as needed.
|
|
Infections and infestations
Urinary tract infection
|
29.4%
5/17 • Number of events 5 • Data were collected over a 15 month period.
Data were collected at scheduled clinic and telephone study visits via medical history, physical examinations, laboratory tests, EKG, and other tests as necessary. In addition, adverse events were reported to site investigators by subjects and their study partners between visits, as needed.
|
|
Injury, poisoning and procedural complications
Contusion
|
5.9%
1/17 • Number of events 1 • Data were collected over a 15 month period.
Data were collected at scheduled clinic and telephone study visits via medical history, physical examinations, laboratory tests, EKG, and other tests as necessary. In addition, adverse events were reported to site investigators by subjects and their study partners between visits, as needed.
|
|
Injury, poisoning and procedural complications
Excoriation
|
5.9%
1/17 • Number of events 2 • Data were collected over a 15 month period.
Data were collected at scheduled clinic and telephone study visits via medical history, physical examinations, laboratory tests, EKG, and other tests as necessary. In addition, adverse events were reported to site investigators by subjects and their study partners between visits, as needed.
|
|
Injury, poisoning and procedural complications
Eye injury
|
5.9%
1/17 • Number of events 1 • Data were collected over a 15 month period.
Data were collected at scheduled clinic and telephone study visits via medical history, physical examinations, laboratory tests, EKG, and other tests as necessary. In addition, adverse events were reported to site investigators by subjects and their study partners between visits, as needed.
|
|
Injury, poisoning and procedural complications
Fall
|
17.6%
3/17 • Number of events 3 • Data were collected over a 15 month period.
Data were collected at scheduled clinic and telephone study visits via medical history, physical examinations, laboratory tests, EKG, and other tests as necessary. In addition, adverse events were reported to site investigators by subjects and their study partners between visits, as needed.
|
|
Injury, poisoning and procedural complications
Laceration
|
5.9%
1/17 • Number of events 2 • Data were collected over a 15 month period.
Data were collected at scheduled clinic and telephone study visits via medical history, physical examinations, laboratory tests, EKG, and other tests as necessary. In addition, adverse events were reported to site investigators by subjects and their study partners between visits, as needed.
|
|
Injury, poisoning and procedural complications
Skin laceration
|
5.9%
1/17 • Number of events 1 • Data were collected over a 15 month period.
Data were collected at scheduled clinic and telephone study visits via medical history, physical examinations, laboratory tests, EKG, and other tests as necessary. In addition, adverse events were reported to site investigators by subjects and their study partners between visits, as needed.
|
|
Investigations
Alanine aminotransferase increased
|
5.9%
1/17 • Number of events 1 • Data were collected over a 15 month period.
Data were collected at scheduled clinic and telephone study visits via medical history, physical examinations, laboratory tests, EKG, and other tests as necessary. In addition, adverse events were reported to site investigators by subjects and their study partners between visits, as needed.
|
|
Investigations
Aspartate aminotransferase increased
|
5.9%
1/17 • Number of events 1 • Data were collected over a 15 month period.
Data were collected at scheduled clinic and telephone study visits via medical history, physical examinations, laboratory tests, EKG, and other tests as necessary. In addition, adverse events were reported to site investigators by subjects and their study partners between visits, as needed.
|
|
Investigations
Blood cholesterol increased
|
5.9%
1/17 • Number of events 1 • Data were collected over a 15 month period.
Data were collected at scheduled clinic and telephone study visits via medical history, physical examinations, laboratory tests, EKG, and other tests as necessary. In addition, adverse events were reported to site investigators by subjects and their study partners between visits, as needed.
|
|
Investigations
Blood creatine increased
|
5.9%
1/17 • Number of events 1 • Data were collected over a 15 month period.
Data were collected at scheduled clinic and telephone study visits via medical history, physical examinations, laboratory tests, EKG, and other tests as necessary. In addition, adverse events were reported to site investigators by subjects and their study partners between visits, as needed.
|
|
Investigations
Blood glucose increased
|
17.6%
3/17 • Number of events 3 • Data were collected over a 15 month period.
Data were collected at scheduled clinic and telephone study visits via medical history, physical examinations, laboratory tests, EKG, and other tests as necessary. In addition, adverse events were reported to site investigators by subjects and their study partners between visits, as needed.
|
|
Investigations
Blood thyroid stimulating hormone increased
|
5.9%
1/17 • Number of events 1 • Data were collected over a 15 month period.
Data were collected at scheduled clinic and telephone study visits via medical history, physical examinations, laboratory tests, EKG, and other tests as necessary. In addition, adverse events were reported to site investigators by subjects and their study partners between visits, as needed.
|
|
Investigations
Thyroxine increased
|
5.9%
1/17 • Number of events 1 • Data were collected over a 15 month period.
Data were collected at scheduled clinic and telephone study visits via medical history, physical examinations, laboratory tests, EKG, and other tests as necessary. In addition, adverse events were reported to site investigators by subjects and their study partners between visits, as needed.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
11.8%
2/17 • Number of events 2 • Data were collected over a 15 month period.
Data were collected at scheduled clinic and telephone study visits via medical history, physical examinations, laboratory tests, EKG, and other tests as necessary. In addition, adverse events were reported to site investigators by subjects and their study partners between visits, as needed.
|
|
Metabolism and nutrition disorders
Dehydration
|
5.9%
1/17 • Number of events 1 • Data were collected over a 15 month period.
Data were collected at scheduled clinic and telephone study visits via medical history, physical examinations, laboratory tests, EKG, and other tests as necessary. In addition, adverse events were reported to site investigators by subjects and their study partners between visits, as needed.
|
|
Metabolism and nutrition disorders
Hypercalcaemia
|
5.9%
1/17 • Number of events 1 • Data were collected over a 15 month period.
Data were collected at scheduled clinic and telephone study visits via medical history, physical examinations, laboratory tests, EKG, and other tests as necessary. In addition, adverse events were reported to site investigators by subjects and their study partners between visits, as needed.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
5.9%
1/17 • Number of events 1 • Data were collected over a 15 month period.
Data were collected at scheduled clinic and telephone study visits via medical history, physical examinations, laboratory tests, EKG, and other tests as necessary. In addition, adverse events were reported to site investigators by subjects and their study partners between visits, as needed.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
5.9%
1/17 • Number of events 1 • Data were collected over a 15 month period.
Data were collected at scheduled clinic and telephone study visits via medical history, physical examinations, laboratory tests, EKG, and other tests as necessary. In addition, adverse events were reported to site investigators by subjects and their study partners between visits, as needed.
|
|
Musculoskeletal and connective tissue disorders
Muscle rigidity
|
17.6%
3/17 • Number of events 5 • Data were collected over a 15 month period.
Data were collected at scheduled clinic and telephone study visits via medical history, physical examinations, laboratory tests, EKG, and other tests as necessary. In addition, adverse events were reported to site investigators by subjects and their study partners between visits, as needed.
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
5.9%
1/17 • Number of events 1 • Data were collected over a 15 month period.
Data were collected at scheduled clinic and telephone study visits via medical history, physical examinations, laboratory tests, EKG, and other tests as necessary. In addition, adverse events were reported to site investigators by subjects and their study partners between visits, as needed.
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
5.9%
1/17 • Number of events 1 • Data were collected over a 15 month period.
Data were collected at scheduled clinic and telephone study visits via medical history, physical examinations, laboratory tests, EKG, and other tests as necessary. In addition, adverse events were reported to site investigators by subjects and their study partners between visits, as needed.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal stiffness
|
5.9%
1/17 • Number of events 1 • Data were collected over a 15 month period.
Data were collected at scheduled clinic and telephone study visits via medical history, physical examinations, laboratory tests, EKG, and other tests as necessary. In addition, adverse events were reported to site investigators by subjects and their study partners between visits, as needed.
|
|
Musculoskeletal and connective tissue disorders
Posture abnormal
|
5.9%
1/17 • Number of events 1 • Data were collected over a 15 month period.
Data were collected at scheduled clinic and telephone study visits via medical history, physical examinations, laboratory tests, EKG, and other tests as necessary. In addition, adverse events were reported to site investigators by subjects and their study partners between visits, as needed.
|
|
Musculoskeletal and connective tissue disorders
Rotator cuff syndrome
|
5.9%
1/17 • Number of events 1 • Data were collected over a 15 month period.
Data were collected at scheduled clinic and telephone study visits via medical history, physical examinations, laboratory tests, EKG, and other tests as necessary. In addition, adverse events were reported to site investigators by subjects and their study partners between visits, as needed.
|
|
Nervous system disorders
Akinesia
|
5.9%
1/17 • Number of events 1 • Data were collected over a 15 month period.
Data were collected at scheduled clinic and telephone study visits via medical history, physical examinations, laboratory tests, EKG, and other tests as necessary. In addition, adverse events were reported to site investigators by subjects and their study partners between visits, as needed.
|
|
Nervous system disorders
Aphasia
|
5.9%
1/17 • Number of events 2 • Data were collected over a 15 month period.
Data were collected at scheduled clinic and telephone study visits via medical history, physical examinations, laboratory tests, EKG, and other tests as necessary. In addition, adverse events were reported to site investigators by subjects and their study partners between visits, as needed.
|
|
Nervous system disorders
Apraxia
|
11.8%
2/17 • Number of events 2 • Data were collected over a 15 month period.
Data were collected at scheduled clinic and telephone study visits via medical history, physical examinations, laboratory tests, EKG, and other tests as necessary. In addition, adverse events were reported to site investigators by subjects and their study partners between visits, as needed.
|
|
Nervous system disorders
Clonus
|
5.9%
1/17 • Number of events 1 • Data were collected over a 15 month period.
Data were collected at scheduled clinic and telephone study visits via medical history, physical examinations, laboratory tests, EKG, and other tests as necessary. In addition, adverse events were reported to site investigators by subjects and their study partners between visits, as needed.
|
|
Nervous system disorders
Dizziness
|
5.9%
1/17 • Number of events 1 • Data were collected over a 15 month period.
Data were collected at scheduled clinic and telephone study visits via medical history, physical examinations, laboratory tests, EKG, and other tests as necessary. In addition, adverse events were reported to site investigators by subjects and their study partners between visits, as needed.
|
|
Nervous system disorders
Dysarthria
|
17.6%
3/17 • Number of events 4 • Data were collected over a 15 month period.
Data were collected at scheduled clinic and telephone study visits via medical history, physical examinations, laboratory tests, EKG, and other tests as necessary. In addition, adverse events were reported to site investigators by subjects and their study partners between visits, as needed.
|
|
Nervous system disorders
Dysstasia
|
11.8%
2/17 • Number of events 2 • Data were collected over a 15 month period.
Data were collected at scheduled clinic and telephone study visits via medical history, physical examinations, laboratory tests, EKG, and other tests as necessary. In addition, adverse events were reported to site investigators by subjects and their study partners between visits, as needed.
|
|
Nervous system disorders
Dystonia
|
11.8%
2/17 • Number of events 2 • Data were collected over a 15 month period.
Data were collected at scheduled clinic and telephone study visits via medical history, physical examinations, laboratory tests, EKG, and other tests as necessary. In addition, adverse events were reported to site investigators by subjects and their study partners between visits, as needed.
|
|
Nervous system disorders
Headache
|
5.9%
1/17 • Number of events 2 • Data were collected over a 15 month period.
Data were collected at scheduled clinic and telephone study visits via medical history, physical examinations, laboratory tests, EKG, and other tests as necessary. In addition, adverse events were reported to site investigators by subjects and their study partners between visits, as needed.
|
|
Nervous system disorders
Hypokinesia
|
23.5%
4/17 • Number of events 8 • Data were collected over a 15 month period.
Data were collected at scheduled clinic and telephone study visits via medical history, physical examinations, laboratory tests, EKG, and other tests as necessary. In addition, adverse events were reported to site investigators by subjects and their study partners between visits, as needed.
|
|
Nervous system disorders
Lethargy
|
5.9%
1/17 • Number of events 1 • Data were collected over a 15 month period.
Data were collected at scheduled clinic and telephone study visits via medical history, physical examinations, laboratory tests, EKG, and other tests as necessary. In addition, adverse events were reported to site investigators by subjects and their study partners between visits, as needed.
|
|
Nervous system disorders
Mental impairment
|
5.9%
1/17 • Number of events 2 • Data were collected over a 15 month period.
Data were collected at scheduled clinic and telephone study visits via medical history, physical examinations, laboratory tests, EKG, and other tests as necessary. In addition, adverse events were reported to site investigators by subjects and their study partners between visits, as needed.
|
|
Nervous system disorders
Myoclonus
|
5.9%
1/17 • Number of events 1 • Data were collected over a 15 month period.
Data were collected at scheduled clinic and telephone study visits via medical history, physical examinations, laboratory tests, EKG, and other tests as necessary. In addition, adverse events were reported to site investigators by subjects and their study partners between visits, as needed.
|
|
Nervous system disorders
Speech disorder
|
11.8%
2/17 • Number of events 3 • Data were collected over a 15 month period.
Data were collected at scheduled clinic and telephone study visits via medical history, physical examinations, laboratory tests, EKG, and other tests as necessary. In addition, adverse events were reported to site investigators by subjects and their study partners between visits, as needed.
|
|
Nervous system disorders
Tremor
|
58.8%
10/17 • Number of events 13 • Data were collected over a 15 month period.
Data were collected at scheduled clinic and telephone study visits via medical history, physical examinations, laboratory tests, EKG, and other tests as necessary. In addition, adverse events were reported to site investigators by subjects and their study partners between visits, as needed.
|
|
Psychiatric disorders
Cognitive deterioration
|
11.8%
2/17 • Number of events 2 • Data were collected over a 15 month period.
Data were collected at scheduled clinic and telephone study visits via medical history, physical examinations, laboratory tests, EKG, and other tests as necessary. In addition, adverse events were reported to site investigators by subjects and their study partners between visits, as needed.
|
|
Psychiatric disorders
Confusional state
|
11.8%
2/17 • Number of events 2 • Data were collected over a 15 month period.
Data were collected at scheduled clinic and telephone study visits via medical history, physical examinations, laboratory tests, EKG, and other tests as necessary. In addition, adverse events were reported to site investigators by subjects and their study partners between visits, as needed.
|
|
Psychiatric disorders
Depressed mood
|
5.9%
1/17 • Number of events 1 • Data were collected over a 15 month period.
Data were collected at scheduled clinic and telephone study visits via medical history, physical examinations, laboratory tests, EKG, and other tests as necessary. In addition, adverse events were reported to site investigators by subjects and their study partners between visits, as needed.
|
|
Psychiatric disorders
Disorientation
|
5.9%
1/17 • Number of events 1 • Data were collected over a 15 month period.
Data were collected at scheduled clinic and telephone study visits via medical history, physical examinations, laboratory tests, EKG, and other tests as necessary. In addition, adverse events were reported to site investigators by subjects and their study partners between visits, as needed.
|
|
Psychiatric disorders
Hallucination, visual
|
5.9%
1/17 • Number of events 1 • Data were collected over a 15 month period.
Data were collected at scheduled clinic and telephone study visits via medical history, physical examinations, laboratory tests, EKG, and other tests as necessary. In addition, adverse events were reported to site investigators by subjects and their study partners between visits, as needed.
|
|
Psychiatric disorders
Insomnia
|
5.9%
1/17 • Number of events 1 • Data were collected over a 15 month period.
Data were collected at scheduled clinic and telephone study visits via medical history, physical examinations, laboratory tests, EKG, and other tests as necessary. In addition, adverse events were reported to site investigators by subjects and their study partners between visits, as needed.
|
|
Psychiatric disorders
Mood altered
|
11.8%
2/17 • Number of events 2 • Data were collected over a 15 month period.
Data were collected at scheduled clinic and telephone study visits via medical history, physical examinations, laboratory tests, EKG, and other tests as necessary. In addition, adverse events were reported to site investigators by subjects and their study partners between visits, as needed.
|
|
Psychiatric disorders
Poverty of speech
|
5.9%
1/17 • Number of events 1 • Data were collected over a 15 month period.
Data were collected at scheduled clinic and telephone study visits via medical history, physical examinations, laboratory tests, EKG, and other tests as necessary. In addition, adverse events were reported to site investigators by subjects and their study partners between visits, as needed.
|
|
Psychiatric disorders
Social avoidant behavior
|
5.9%
1/17 • Number of events 1 • Data were collected over a 15 month period.
Data were collected at scheduled clinic and telephone study visits via medical history, physical examinations, laboratory tests, EKG, and other tests as necessary. In addition, adverse events were reported to site investigators by subjects and their study partners between visits, as needed.
|
|
Psychiatric disorders
Staring
|
5.9%
1/17 • Number of events 1 • Data were collected over a 15 month period.
Data were collected at scheduled clinic and telephone study visits via medical history, physical examinations, laboratory tests, EKG, and other tests as necessary. In addition, adverse events were reported to site investigators by subjects and their study partners between visits, as needed.
|
|
Renal and urinary disorders
Incontinence
|
5.9%
1/17 • Number of events 1 • Data were collected over a 15 month period.
Data were collected at scheduled clinic and telephone study visits via medical history, physical examinations, laboratory tests, EKG, and other tests as necessary. In addition, adverse events were reported to site investigators by subjects and their study partners between visits, as needed.
|
|
Renal and urinary disorders
Urinary hesitation
|
5.9%
1/17 • Number of events 1 • Data were collected over a 15 month period.
Data were collected at scheduled clinic and telephone study visits via medical history, physical examinations, laboratory tests, EKG, and other tests as necessary. In addition, adverse events were reported to site investigators by subjects and their study partners between visits, as needed.
|
|
Renal and urinary disorders
Urinary incontinence
|
5.9%
1/17 • Number of events 1 • Data were collected over a 15 month period.
Data were collected at scheduled clinic and telephone study visits via medical history, physical examinations, laboratory tests, EKG, and other tests as necessary. In addition, adverse events were reported to site investigators by subjects and their study partners between visits, as needed.
|
|
Respiratory, thoracic and mediastinal disorders
Atelectasis
|
5.9%
1/17 • Number of events 1 • Data were collected over a 15 month period.
Data were collected at scheduled clinic and telephone study visits via medical history, physical examinations, laboratory tests, EKG, and other tests as necessary. In addition, adverse events were reported to site investigators by subjects and their study partners between visits, as needed.
|
|
Respiratory, thoracic and mediastinal disorders
Choking
|
5.9%
1/17 • Number of events 1 • Data were collected over a 15 month period.
Data were collected at scheduled clinic and telephone study visits via medical history, physical examinations, laboratory tests, EKG, and other tests as necessary. In addition, adverse events were reported to site investigators by subjects and their study partners between visits, as needed.
|
|
Respiratory, thoracic and mediastinal disorders
Dysphonia
|
5.9%
1/17 • Number of events 2 • Data were collected over a 15 month period.
Data were collected at scheduled clinic and telephone study visits via medical history, physical examinations, laboratory tests, EKG, and other tests as necessary. In addition, adverse events were reported to site investigators by subjects and their study partners between visits, as needed.
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
5.9%
1/17 • Number of events 1 • Data were collected over a 15 month period.
Data were collected at scheduled clinic and telephone study visits via medical history, physical examinations, laboratory tests, EKG, and other tests as necessary. In addition, adverse events were reported to site investigators by subjects and their study partners between visits, as needed.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
5.9%
1/17 • Number of events 1 • Data were collected over a 15 month period.
Data were collected at scheduled clinic and telephone study visits via medical history, physical examinations, laboratory tests, EKG, and other tests as necessary. In addition, adverse events were reported to site investigators by subjects and their study partners between visits, as needed.
|
|
Skin and subcutaneous tissue disorders
Rash
|
5.9%
1/17 • Number of events 1 • Data were collected over a 15 month period.
Data were collected at scheduled clinic and telephone study visits via medical history, physical examinations, laboratory tests, EKG, and other tests as necessary. In addition, adverse events were reported to site investigators by subjects and their study partners between visits, as needed.
|
|
Social circumstances
Activities of daily living impaired
|
5.9%
1/17 • Number of events 1 • Data were collected over a 15 month period.
Data were collected at scheduled clinic and telephone study visits via medical history, physical examinations, laboratory tests, EKG, and other tests as necessary. In addition, adverse events were reported to site investigators by subjects and their study partners between visits, as needed.
|
|
Gastrointestinal disorders
Volvulus of bowel
|
5.9%
1/17 • Number of events 1 • Data were collected over a 15 month period.
Data were collected at scheduled clinic and telephone study visits via medical history, physical examinations, laboratory tests, EKG, and other tests as necessary. In addition, adverse events were reported to site investigators by subjects and their study partners between visits, as needed.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee The Publication Policy for the National Institute of Neurological Disorders and Stroke (NINDS) Pilot Therapeutic Trials Network (NPTUNE) outlines procedures for the development and review of concept sheets, abstracts, publications, presentations. Investigators must submit an application to the NPTUNE Publications Committee for the use of data. A Writing Committee, appointed by the Publications Committee, is responsible for initiating, coordinating, and approving publications and presentations.
- Publication restrictions are in place
Restriction type: OTHER