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

NCT03179345 | Completed Phase 4 Results

• 1 other identifier: GRAL-PX-8401
• Study Type: interventional
• Target: 32
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Healthy

Keywords

Volunteer; Pharmacodynamics; Pharmacokinetics

Outcome Measures

Primary Outcomes (1)

• Change From Baseline in the "Standard Deviation of the Lateral Position" (SDLP) Measured on the Driving Simulator Between Gralise® and Neurontin®

  SDLP (feet): This is a measurement of change from maintaining the normal driving position in the lane over time and / or distance.

  Baseline and Hour 3 on Day 3

Secondary Outcomes (11)

• Change From Baseline in the "Standard Deviation of the Lateral Position" (SDLP) Measured on the Driving Simulator Between Gralise® and Lyrica®

  Baseline and Hour 3 on Day 3

• Change From Baseline Between, Gralise® and Neurontin®, Gralise® and Lyrica® for Cognitive Evaluation of Cogstate - Detection Task (DET)

  Baseline and Hour 3 on Day 3

• Change From Baseline Between, Gralise® and Neurontin®, Gralise® and Lyrica® for Cognitive Evaluation of Cogstate - Groton Maze Learning Test (GMLT).

  Baseline and Hour 3 on Day 3

• Change From Baseline Between, Gralise® and Neurontin®, Gralise® and Lyrica® for Cognitive Evaluation of Cogstate - Identification Task (IDN).

  Baseline and Hour 3 on Day 3

• Change From Baseline Between, Gralise® and Neurontin®, Gralise® and Lyrica® for Cognitive Evaluation of Cogstate - International Shopping List Test (ISL)

  Baseline and Hour 3 on Day 3

Study Arms (4)

Gralise® (gabapentin)

ACTIVE COMPARATOR

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.

Drug: Gabapentin

Neurontin® (gabapentin)

ACTIVE COMPARATOR

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®.

Drug: Gabapentin

Lyrica® (pregabalin)

ACTIVE COMPARATOR

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®.

Drug: Pregabalin

Placebo (sugar pill)

PLACEBO COMPARATOR

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®.

Other: Placebo

Interventions

Gabapentin DRUG

Also known as: Gralise®, Neurontin®

Gralise® (gabapentin); Neurontin® (gabapentin)

Pregabalin DRUG

Also known as: Lyrica®

Lyrica® (pregabalin)

Placebo OTHER

Also known as: Sugar Pill

Placebo (sugar pill)

Eligibility Criteria

• Age: 40 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Depomed: lead

Related Publications (1)

• Schmidt P, Rao S. Effects of gabapentin, pregabalin and gastroretentive gabapentin on simulated driving, daytime sedation and cognition. Pain Manag. 2018 Jul 1;8(4):297-306. doi: 10.2217/pmt-2018-0005. Epub 2018 Apr 19.

  PMID: 29671676 DERIVED

MeSH Terms

Interventions

Gabapentin; Pregabalin; Sugars

Intervention Hierarchy (Ancestors)

Amines; Organic Chemicals; gamma-Aminobutyric Acid; Aminobutyrates; Butyrates; Acids, Acyclic; Carboxylic Acids; Cyclohexanecarboxylic Acids; Acids, Carbocyclic; Cyclohexanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Amino Acids; Amino Acids, Peptides, and Proteins; Carbohydrates

Results Point of Contact

• Title: Clinical Operations
• Organization: Depomed

clinicaltrials@depomed.com

510-744-8000

Study Officials

• Head of R&D

  Depomed

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 5, 2017
• First Posted: June 7, 2017
• Study Start: September 24, 2015
• Primary Completion: November 20, 2015
• Study Completion: November 20, 2015
• Last Updated: June 1, 2020
• Results First Posted: May 13, 2020

Record last verified: 2020-04