Trial Outcomes & Findings for Safety and Efficacy Study of Vigabatrin to Treat Methamphetamine Dependence (NCT NCT00730522)
NCT ID: NCT00730522
Last Updated: 2020-12-09
Results Overview
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
55 participants
Primary outcome timeframe
Weeks 11-12
Results posted on
2020-12-09
Participant Flow
Participant milestones
| Measure |
Vigabatrin Tablets
CPP-109 vigabatrin tablets (3.0 gm/day) for 12 weeks including 2 week dose escalation
CPP-109 vigabatrin: tablets, bid for 12 weeks
|
Matching Placebo Tablets
Matching Placebo Tablets for 12 weeks on a schedule to match active arm
Matching Placebo: tablets, bid
|
|---|---|---|
|
Overall Study
STARTED
|
28
|
27
|
|
Overall Study
COMPLETED
|
28
|
27
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Vigabatrin
n=28 Participants
CPP-109 vigabatrin tablets
CPP-109 vigabatrin: tablets, bid for 12 weeks
|
Matching Placebo
n=27 Participants
Matching Placebo Tablets
Matching Placebo: tablets, bid, 12 weeks
|
Total
n=55 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=28 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=55 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
28 Participants
n=28 Participants
|
27 Participants
n=27 Participants
|
55 Participants
n=55 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=28 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=55 Participants
|
|
Age, Continuous
|
44 years
n=28 Participants
|
42 years
n=27 Participants
|
43 years
n=55 Participants
|
|
Sex: Female, Male
Female
|
19 Participants
n=28 Participants
|
18 Participants
n=27 Participants
|
37 Participants
n=55 Participants
|
|
Sex: Female, Male
Male
|
9 Participants
n=28 Participants
|
9 Participants
n=27 Participants
|
18 Participants
n=55 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Region of Enrollment
United States
|
28 participants
n=28 Participants
|
27 participants
n=27 Participants
|
55 participants
n=55 Participants
|
|
Methamphetamine substance dependence
|
28 Participants
n=28 Participants
|
27 Participants
n=27 Participants
|
55 Participants
n=55 Participants
|
PRIMARY outcome
Timeframe: Weeks 11-12Outcome measures
| Measure |
Vigabatrin
n=28 Participants
CPP-109 vigabatrin tablets
CPP-109 vigabatrin: tablets, bid for 12 weeks
|
Placebo
n=27 Participants
Matching Placebo Tablets
Matching Placebo: tablets, bid, 12 weeks
|
|---|---|---|
|
The Proportion of Subjects in Each Treatment Group Who Are Amphetamine Abstinent During the Last 2 Weeks of the Treatment Phase (Weeks 11 and 12).
|
4 Participants
|
2 Participants
|
SECONDARY outcome
Timeframe: Weeks 1-12Population: Data were not collected due to early study termination.
Outcome measures
Outcome data not reported
Adverse Events
Vigabatrin
Serious events: 2 serious events
Other events: 24 other events
Deaths: 0 deaths
Placebo
Serious events: 0 serious events
Other events: 23 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Vigabatrin
n=28 participants at risk
CPP-109 vigabatrin tablets
CPP-109 vigabatrin: tablets, bid for 12 weeks
|
Placebo
n=27 participants at risk
Matching Placebo Tablets
Matching Placebo: tablets, bid, 12 weeks
|
|---|---|---|
|
General disorders
Hernia obstructive
|
3.6%
1/28 • 12 weeks
|
0.00%
0/27 • 12 weeks
|
|
Injury, poisoning and procedural complications
fracture
|
3.6%
1/28 • 12 weeks
|
0.00%
0/27 • 12 weeks
|
Other adverse events
| Measure |
Vigabatrin
n=28 participants at risk
CPP-109 vigabatrin tablets
CPP-109 vigabatrin: tablets, bid for 12 weeks
|
Placebo
n=27 participants at risk
Matching Placebo Tablets
Matching Placebo: tablets, bid, 12 weeks
|
|---|---|---|
|
General disorders
Fatigue
|
0.00%
0/28 • 12 weeks
|
3.7%
1/27 • 12 weeks
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/28 • 12 weeks
|
3.7%
1/27 • 12 weeks
|
|
Infections and infestations
Nasopharyngitis
|
7.1%
2/28 • 12 weeks
|
3.7%
1/27 • 12 weeks
|
|
Nervous system disorders
Dizziness
|
3.6%
1/28 • 12 weeks
|
7.4%
2/27 • 12 weeks
|
|
Psychiatric disorders
Depression
|
0.00%
0/28 • 12 weeks
|
7.4%
2/27 • 12 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory tract congestion
|
3.6%
1/28 • 12 weeks
|
3.7%
1/27 • 12 weeks
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/28 • 12 weeks
|
7.4%
2/27 • 12 weeks
|
|
Musculoskeletal and connective tissue disorders
Groin pain
|
0.00%
0/28 • 12 weeks
|
3.7%
1/27 • 12 weeks
|
|
Gastrointestinal disorders
Toothache
|
3.6%
1/28 • 12 weeks
|
3.7%
1/27 • 12 weeks
|
|
Infections and infestations
Influenza
|
0.00%
0/28 • 12 weeks
|
3.7%
1/27 • 12 weeks
|
|
Reproductive system and breast disorders
Menstruation irregular
|
0.00%
0/28 • 12 weeks
|
3.7%
1/27 • 12 weeks
|
|
Psychiatric disorders
Somnolence
|
0.00%
0/28 • 12 weeks
|
3.7%
1/27 • 12 weeks
|
|
Gastrointestinal disorders
Nausea
|
3.6%
1/28 • 12 weeks
|
7.4%
2/27 • 12 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Pharyngolaryngeal pain
|
0.00%
0/28 • 12 weeks
|
3.7%
1/27 • 12 weeks
|
|
Nervous system disorders
Headache
|
10.7%
3/28 • 12 weeks
|
11.1%
3/27 • 12 weeks
|
|
Infections and infestations
Tooth infection
|
3.6%
1/28 • 12 weeks
|
0.00%
0/27 • 12 weeks
|
|
Nervous system disorders
Hypoaesthesia
|
3.6%
1/28 • 12 weeks
|
0.00%
0/27 • 12 weeks
|
|
Psychiatric disorders
Paranoia
|
3.6%
1/28 • 12 weeks
|
0.00%
0/27 • 12 weeks
|
|
Eye disorders
Eye pruritus
|
3.6%
1/28 • 12 weeks
|
0.00%
0/27 • 12 weeks
|
|
Reproductive system and breast disorders
Ovarian Cyst ruptured
|
3.6%
1/28 • 12 weeks
|
0.00%
0/27 • 12 weeks
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
3.6%
1/28 • 12 weeks
|
0.00%
0/27 • 12 weeks
|
|
Gastrointestinal disorders
Constipation
|
3.6%
1/28 • 12 weeks
|
0.00%
0/27 • 12 weeks
|
|
Gastrointestinal disorders
Diarrhoea
|
7.1%
2/28 • 12 weeks
|
0.00%
0/27 • 12 weeks
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
3.6%
1/28 • 12 weeks
|
0.00%
0/27 • 12 weeks
|
|
Gastrointestinal disorders
Abdominal distension
|
3.6%
1/28 • 12 weeks
|
0.00%
0/27 • 12 weeks
|
|
Psychiatric disorders
Confusional state
|
3.6%
1/28 • 12 weeks
|
0.00%
0/27 • 12 weeks
|
|
Skin and subcutaneous tissue disorders
Dermatitis
|
3.6%
1/28 • 12 weeks
|
0.00%
0/27 • 12 weeks
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
3.6%
1/28 • 12 weeks
|
0.00%
0/27 • 12 weeks
|
|
Gastrointestinal disorders
Flatulence
|
3.6%
1/28 • 12 weeks
|
0.00%
0/27 • 12 weeks
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/28 • 12 weeks
|
3.7%
1/27 • 12 weeks
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
0.00%
0/28 • 12 weeks
|
3.7%
1/27 • 12 weeks
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place