Simulated Driving Performance, Daytime Sedation and Cognition in Healthy Volunteers Taking Gralise, Neurontin or Lyrica

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

32 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-09-24

Study Completion Date

2015-11-20

Brief Summary

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Phase 4, double-blind, placebo-controlled, four treatment, four sequence crossover study comparing simulated driving performance, daytime sedation and cognition in healthy volunteers administered therapeutic doses of Gralise® (Treatment A), Neurontin® (Treatment B), Lyrica® (Treatment C) and placebo (Treatment D). All doses were administered under fed conditions.

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Detailed Description

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Conditions

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Healthy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

OTHER

Study Groups

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Gralise® (gabapentin)

Gralise® 3 x 600 mg tablets (1800 mg total dose) administered once daily at 7:00 pm on Day 1 and Day 2 with one placebo capsule matching the over-encapsulation of doses of Neurontin® and Lyrica®. At other dosing times, treatment consisted of 3 placebo tablets matching the appearance of Gralise® and 1 placebo capsule.

Group Type ACTIVE_COMPARATOR

Gabapentin

Intervention Type DRUG

Neurontin® (gabapentin)

Neurontin® 1 x 600 mg film-coated tablet administered 3 times daily at 7:00 pm on Day 1, at 8:00 am, 2:00 pm and 8:00 pm on Day 2 and at 8:00 a.m. on Day 3. Each dose of Neurontin® was over-encapsulated and administered with 3 placebo tablets matching the appearance of Gralise®.

Group Type ACTIVE_COMPARATOR

Gabapentin

Intervention Type DRUG

Lyrica® (pregabalin)

Lyrica® 1 x 150 mg capsule administered 2 times daily at 7:00 pm on Day 1, at 8:00 am and 8:00 pm on Day 2 and at 8:00 a.m. on Day 3. Each dose of Lyrica® was over-encapsulated and administered with 3 placebo tablets matching the appearance of Gralise®.

Group Type ACTIVE_COMPARATOR

Pregabalin

Intervention Type DRUG

Placebo (sugar pill)

Each dose consisted of 3 placebo tablets matching the appearance of Gralise® and 1 placebo capsule matching the over-encapsulation of doses of Neurontin® and Lyrica®.

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type OTHER

Interventions

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Gabapentin

Intervention Type DRUG

Pregabalin

Intervention Type DRUG

Placebo

Intervention Type OTHER

Other Intervention Names

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Gralise®, Neurontin® Lyrica® Sugar Pill

Eligibility Criteria

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Inclusion Criteria

* Between 40 and 80 years of age, inclusive.
* Body weight \> 50 kg and BMI between 18 and 32 kg/m2, inclusive.
* Able to give informed consent.
* Licensed, experienced driver who had driven at least 3 times a week for the past 3 years and had visual acuity adequate for driving, as assessed by the investigator or designee.
* Able to complete a 1 hour simulated driving test and demonstrate satisfactory driving skills, as determined by the investigator or designee.
* Karolinska Sleep Scale (KSS) score of \<=5.
* Other criteria apply.

Exclusion Criteria

* Known history of allergic reaction, hypersensitivity or clinically significant intolerance to gabapentin, pregabalin or any pharmaceutical materials, or any of the ingredients in the protocol-specified meals.
* Pregnant or lactating or considered at risk of pregnancy.
* Any medical condition or any laboratory abnormality or ECG abnormality that would, in the opinion of the investigator, contraindicate study participation.
* Impaired liver function (e.g., alanine aminotransferase \[ALT\] ≥2 times the upper limit of normal \[ULN\] or bilirubin ≥2 times ULN), known active hepatic disease (e.g., hepatitis), or evidence of clinically significant liver disease or other condition affecting the liver that may suggest the potential for an increased susceptibility to hepatic toxicity with oral gabapentin or pregabalin exposure.
* Any history of renal disease that, in the opinion of the investigator, would contraindicate study participation; or subject had significantly impaired renal function as evidenced by an estimated GFR of ≤ 80 ml/min/1.73m2.
* History or evidence of a sleep disorder, including sleep apnea (obstructive, central or mixed), narcolepsy or primary insomnia.
* Other criteria apply.

Minimum Eligible Age

40 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes